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FDA 510(k)

H-H HUNTER PASSIVE TENDON IMPLANT

K-Number: K853436 · 1985-10-16

ApplicantHolter-Hausner Intl.
Decision Date1985-10-16
Product CodeHXR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

H-H HUNTER PASSIVE TENDON IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Holter-Hausner Intl.. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K853436. The device is classified under product code HXR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H-H HUNTER PASSIVE TENDON IMPLANT?

H-H HUNTER PASSIVE TENDON IMPLANT is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Holter-Hausner Intl.. The 510(k) number is K853436.

When did H-H HUNTER PASSIVE TENDON IMPLANT receive FDA 510(k) clearance?

H-H HUNTER PASSIVE TENDON IMPLANT received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853436.

Who is the listed applicant for H-H HUNTER PASSIVE TENDON IMPLANT?

The FDA 510(k) record lists Holter-Hausner Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H-H HUNTER PASSIVE TENDON IMPLANT?

The FDA product code for H-H HUNTER PASSIVE TENDON IMPLANT is HXR.

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Other records listing Holter-Hausner Intl. 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.

K875287H-H FLUSHING RESERVOIRK874508H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAGK872293H-H HUNTER ACTIVE TENDON IMPLANT BCK872285H-H HUNTER ACTIVE TENDON IMPLANT DCK872284H-H HUNTER ACTIVE TENDON IMPLANT PCK871351H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP

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Related Devices (Code: HXR)

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.

K983882MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400Micro-Medical Devices, Inc.K873387VIDEO ARTHROSCOPE, 1.7MM X 55 MMArthropedics, Inc.K872281RAYLOR FUSION FUNNELCedar Surgical, Inc.

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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