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FDA 510(k)

OTOSILK OTOLOGICAL GRAFT DRESSING

K-Number: K964534 · 1997-04-09

ApplicantBoston Medical Products, Inc.
Decision Date1997-04-09
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OTOSILK OTOLOGICAL GRAFT DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Boston Medical Products, Inc.. It received FDA 510(k) clearance on 1997-04-09 under 510(k) number K964534. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTOSILK OTOLOGICAL GRAFT DRESSING?

OTOSILK OTOLOGICAL GRAFT DRESSING is a medical device that received FDA 510(k) clearance on 1997-04-09. The listed applicant is Boston Medical Products, Inc.. The 510(k) number is K964534.

When did OTOSILK OTOLOGICAL GRAFT DRESSING receive FDA 510(k) clearance?

OTOSILK OTOLOGICAL GRAFT DRESSING received FDA 510(k) clearance on 1997-04-09, under 510(k) number K964534.

Who is the listed applicant for OTOSILK OTOLOGICAL GRAFT DRESSING?

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

What is the FDA product code for OTOSILK OTOLOGICAL GRAFT DRESSING?

The FDA product code for OTOSILK OTOLOGICAL GRAFT DRESSING is NAD.

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Other records listing Boston Medical Products, 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.

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Related Devices (Code: NAD)

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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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