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FDA 510(k)

APACERAM OSSICULAR PROSTHESIS

K-Number: K893134 · 1989-08-03

ApplicantAsahi Optical Co. C/O Rosati Associates, P.C.
Decision Date1989-08-03
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

APACERAM OSSICULAR PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Optical Co. C/O Rosati Associates, P.C.. It received FDA 510(k) clearance on 1989-08-03 under 510(k) number K893134. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APACERAM OSSICULAR PROSTHESIS?

APACERAM OSSICULAR PROSTHESIS is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Asahi Optical Co. C/O Rosati Associates, P.C.. The 510(k) number is K893134.

When did APACERAM OSSICULAR PROSTHESIS receive FDA 510(k) clearance?

APACERAM OSSICULAR PROSTHESIS received FDA 510(k) clearance on 1989-08-03, under 510(k) number K893134.

Who is the listed applicant for APACERAM OSSICULAR PROSTHESIS?

The FDA 510(k) record lists Asahi Optical Co. C/O Rosati Associates, P.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APACERAM OSSICULAR PROSTHESIS?

The FDA product code for APACERAM OSSICULAR PROSTHESIS is ETB.

Related Clinical Trials

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Other records listing Asahi Optical Co. C/O Rosati Associates, P.C. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K885133APACERAM ARTIFICIAL DENTAL IMPLANTK872089APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G)K861960ZIMLITE LENS

Related Devices (Code: ETB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260718mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)MED-EL Elektromedizinische Geräte GmbHK260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);MED-EL Elektromedizinische Geräte GmbHK241261mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis KitMED-EL Elektromedizinische Geräte GmbHK241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes ProsthesisMED-EL Elektromedizinische Geräte GmbHK130512NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESISHeinz Kurz GmbH MedizintechnikK112616NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESISHeinz Kurz GmbH Medizintechnik

Official Source

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