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FDA 510(k)

SURGICAL SAW BLADES

K-Number: K934603 · 1994-02-22

ApplicantAmerican Medical Specialties, Inc.
Decision Date1994-02-22
Product CodeGFA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL SAW BLADES is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Specialties, Inc.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K934603. The device is classified under product code GFA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL SAW BLADES?

SURGICAL SAW BLADES is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is American Medical Specialties, Inc.. The 510(k) number is K934603.

When did SURGICAL SAW BLADES receive FDA 510(k) clearance?

SURGICAL SAW BLADES received FDA 510(k) clearance on 1994-02-22, under 510(k) number K934603.

Who is the listed applicant for SURGICAL SAW BLADES?

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

What is the FDA product code for SURGICAL SAW BLADES?

The FDA product code for SURGICAL SAW BLADES is GFA.

Related Clinical Trials

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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Other records listing American Medical Specialties, 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.

K960482K-WIREK960483STEINMAN PINK934583BURRS

Related Devices (Code: GFA)

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.

K971978GRAFT HARVESTING SAWBLADESWrightmedicaltechnologyincK954483STRYKER SAGITTAL SAW ATTACHMENTStryker InstrumentsK955229WRIGHT MEDICAL TECHNOLOGY SAWBLADESWrightmedicaltechnologyincK953012DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLSBoston Surgical Products, Inc.K950403SURGICAL SAW BLADESTransidyne General Corp.K940501RE-SHARPENABLE SAW BLADESAdven Medical

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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