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FDA 510(k)

NON-STERILE GAUZE SPONGE

K-Number: K891054 · 1989-05-01

ApplicantDispomed, Inc.
Decision Date1989-05-01
Product CodeKHR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NON-STERILE GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Dispomed, Inc.. It received FDA 510(k) clearance on 1989-05-01 under 510(k) number K891054. The device is classified under product code KHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-STERILE GAUZE SPONGE?

NON-STERILE GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1989-05-01. The listed applicant is Dispomed, Inc.. The 510(k) number is K891054.

When did NON-STERILE GAUZE SPONGE receive FDA 510(k) clearance?

NON-STERILE GAUZE SPONGE received FDA 510(k) clearance on 1989-05-01, under 510(k) number K891054.

Who is the listed applicant for NON-STERILE GAUZE SPONGE?

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

What is the FDA product code for NON-STERILE GAUZE SPONGE?

The FDA product code for NON-STERILE GAUZE SPONGE is KHR.

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Other records listing Dispomed, 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.

K892748PATIENT EXAM GLOVES (MFG. AMMATEX)K891058DENTAL GOWNK891052SPLASH GUARD GOGGLEK891053DENTAL BIBK891056SURGICAL CONE MASKK891051SURGICAL FACE MASK-EAR LOOP

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Related Devices (Code: KHR)

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.

K980783SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5Irt Management Corp.K954068GENERAL HYGIENE KITPhysician Industries, Inc.K953812GAUZE SPONGERemington Medical, Inc.K891354ORTHODONTIC COTTON ROLL HOLDERSAmerican OrthodonticsK890734DRY TIPSMicrocopy, Div. Neo-Flo, Inc.K870383ALGINATE WOOL FIBERAdri

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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