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FDA 510(k)

STERILE GAUZE PADS

K-Number: K915591 · 1993-01-27

ApplicantEagle Medical, Inc.
Decision Date1993-01-27
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE GAUZE PADS is the device name listed in this FDA 510(k) record. The listed applicant is Eagle Medical, Inc.. It received FDA 510(k) clearance on 1993-01-27 under 510(k) number K915591. 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?

STERILE GAUZE PADS is a medical device that received FDA 510(k) clearance on 1993-01-27. The listed applicant is Eagle Medical, Inc.. The 510(k) number is K915591.

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

STERILE GAUZE PADS received FDA 510(k) clearance on 1993-01-27, under 510(k) number K915591.

Who is the listed applicant for STERILE GAUZE PADS?

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

What is the FDA product code for STERILE GAUZE PADS?

The FDA product code for STERILE GAUZE PADS is NAB.

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Other records listing Eagle Medical, 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.

K933661INSUFFLATOR TUBING KIT W/FILTERK891795DISPOSABLE LATEX EXAM GLOVES

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.K924650GAUZE SPONGESDav-Mar Medical Products, 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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