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FDA 510(k)

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE

K-Number: K905482 · 1991-03-14

ApplicantPfizer Hospital Products Group, Inc.
Decision Date1991-03-14
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer Hospital Products Group, Inc.. It received FDA 510(k) clearance on 1991-03-14 under 510(k) number K905482. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE?

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE is a medical device that received FDA 510(k) clearance on 1991-03-14. The listed applicant is Pfizer Hospital Products Group, Inc.. The 510(k) number is K905482.

When did BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE receive FDA 510(k) clearance?

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE received FDA 510(k) clearance on 1991-03-14, under 510(k) number K905482.

Who is the listed applicant for BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE?

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

What is the FDA product code for BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE?

The FDA product code for BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE is GAM.

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Other records listing Pfizer Hospital Products Group, Inc. as applicant

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Related Devices (Code: GAM)

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.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

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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