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FDA 510(k)

GENERAL AND PLASTIC SURGERY PACKS

K-Number: K951478 · 1995-06-13

ApplicantSterile Concepts, Inc.
Decision Date1995-06-13
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENERAL AND PLASTIC SURGERY PACKS is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Concepts, Inc.. It received FDA 510(k) clearance on 1995-06-13 under 510(k) number K951478. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENERAL AND PLASTIC SURGERY PACKS?

GENERAL AND PLASTIC SURGERY PACKS is a medical device that received FDA 510(k) clearance on 1995-06-13. The listed applicant is Sterile Concepts, Inc.. The 510(k) number is K951478.

When did GENERAL AND PLASTIC SURGERY PACKS receive FDA 510(k) clearance?

GENERAL AND PLASTIC SURGERY PACKS received FDA 510(k) clearance on 1995-06-13, under 510(k) number K951478.

Who is the listed applicant for GENERAL AND PLASTIC SURGERY PACKS?

The FDA 510(k) record lists Sterile Concepts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENERAL AND PLASTIC SURGERY PACKS?

The FDA product code for GENERAL AND PLASTIC SURGERY PACKS is LRO.

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Other records listing Sterile Concepts, Inc. 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.

K951231ORTHOPEDIC PACKSK951081OB/GYN PACKSK952539RADIOLOGY PACKSK944139DENTAL HYGIENE TRAYK943047IV START KITSK943090SUTURE REMOVAL TRAYS

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Related Devices (Code: LRO)

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.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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