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FDA 510(k)

LAPAROTOMY SPONGES, STERILE

K-Number: K771395 · 1977-08-19

ApplicantMedline Industries, Inc.
Decision Date1977-08-19
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAPAROTOMY SPONGES, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 1977-08-19 under 510(k) number K771395. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROTOMY SPONGES, STERILE?

LAPAROTOMY SPONGES, STERILE is a medical device that received FDA 510(k) clearance on 1977-08-19. The listed applicant is Medline Industries, Inc.. The 510(k) number is K771395.

When did LAPAROTOMY SPONGES, STERILE receive FDA 510(k) clearance?

LAPAROTOMY SPONGES, STERILE received FDA 510(k) clearance on 1977-08-19, under 510(k) number K771395.

Who is the listed applicant for LAPAROTOMY SPONGES, STERILE?

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

What is the FDA product code for LAPAROTOMY SPONGES, STERILE?

The FDA product code for LAPAROTOMY SPONGES, STERILE is GDY.

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Related Devices (Code: GDY)

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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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