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FDA 510(k)

BAND-AGE ICE-BANDAGE

K-Number: K761254 · 1977-02-24

ApplicantSurgicot, Inc.
Decision Date1977-02-24
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BAND-AGE ICE-BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Surgicot, Inc.. It received FDA 510(k) clearance on 1977-02-24 under 510(k) number K761254. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAND-AGE ICE-BANDAGE?

BAND-AGE ICE-BANDAGE is a medical device that received FDA 510(k) clearance on 1977-02-24. The listed applicant is Surgicot, Inc.. The 510(k) number is K761254.

When did BAND-AGE ICE-BANDAGE receive FDA 510(k) clearance?

BAND-AGE ICE-BANDAGE received FDA 510(k) clearance on 1977-02-24, under 510(k) number K761254.

Who is the listed applicant for BAND-AGE ICE-BANDAGE?

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

What is the FDA product code for BAND-AGE ICE-BANDAGE?

The FDA product code for BAND-AGE ICE-BANDAGE is ILO.

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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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