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FDA 510(k)

PROTECT IV GARD

K-Number: K772060 · 1977-12-20

ApplicantOmnicon Medical Corp.
Decision Date1977-12-20
Product CodeFMP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROTECT IV GARD is the device name listed in this FDA 510(k) record. The listed applicant is Omnicon Medical Corp.. It received FDA 510(k) clearance on 1977-12-20 under 510(k) number K772060. The device is classified under product code FMP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTECT IV GARD?

PROTECT IV GARD is a medical device that received FDA 510(k) clearance on 1977-12-20. The listed applicant is Omnicon Medical Corp.. The 510(k) number is K772060.

When did PROTECT IV GARD receive FDA 510(k) clearance?

PROTECT IV GARD received FDA 510(k) clearance on 1977-12-20, under 510(k) number K772060.

Who is the listed applicant for PROTECT IV GARD?

The FDA 510(k) record lists Omnicon Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTECT IV GARD?

The FDA product code for PROTECT IV GARD is FMP.

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Other records listing Omnicon Medical Corp. 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.

K823872EMERGENCY TRACHEOSTOMY KITK820577ANESTHESIA BACTERIA FILTERK820576MAINFLOW BACTERIA FILTERK801803MAINFLOW BACTERIA FILTERK801804ANESTHESIA BACTERIA FILTERK770136DISPOSABLE BACTERIA FILTER

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Related Devices (Code: FMP)

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.

K951325COMFEEL PLUS PRESSURE RELIEF DRESSINGRichard Hamer Assoc., Inc.K934731MEDSURG STERILE IMAGING PRODUCTSMedsurg Industries, Inc.K820584DECUBICARE PADS & ACCESSORIESAbco Dealers, Inc.K812344HEEL OR ELBOW PROTECTORFred Sammons, Inc.K811184SPENCO DERMAL PADSSpenco Medical Corp.K802829SCANLAN VASCU-STATTScanlan Intl., 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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