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FDA 510(k)

STERILE GAUZE PADS 12PLY

K-Number: K812711 · 1981-11-02

ApplicantMedspec Corp.
Decision Date1981-11-02
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE GAUZE PADS 12PLY is the device name listed in this FDA 510(k) record. The listed applicant is Medspec Corp.. It received FDA 510(k) clearance on 1981-11-02 under 510(k) number K812711. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE GAUZE PADS 12PLY?

STERILE GAUZE PADS 12PLY is a medical device that received FDA 510(k) clearance on 1981-11-02. The listed applicant is Medspec Corp.. The 510(k) number is K812711.

When did STERILE GAUZE PADS 12PLY receive FDA 510(k) clearance?

STERILE GAUZE PADS 12PLY received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812711.

Who is the listed applicant for STERILE GAUZE PADS 12PLY?

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

What is the FDA product code for STERILE GAUZE PADS 12PLY?

The FDA product code for STERILE GAUZE PADS 12PLY is NAB.

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Other records listing Medspec 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.

K813012STERILE BASIN SETSK812707STERILE DISSECTOR SPONGES-X-RAY DETECTK812710STERILE LAPAROTOMY SPONGES-X-RAY DETECTK812709STERILE DENTAL ROLLK810071STERILE SILICONE TUBINGK810069STERILE AIRWAY

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Related Devices (Code: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, 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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