FDA 510(k)

CERTI COOL INSTANT COLD COMPRESS

K-Number: K960624 · 1996-05-06

Decision Date1996-05-06

Product CodeIMD

Advisory CommitteePM

DecisionSubstantially Equivalent for Some Indications

Device Summary

CERTI COOL INSTANT COLD COMPRESS is the device name listed in this FDA 510(k) record. The listed applicant is Certified Safety Mfg., Inc.. It received FDA 510(k) clearance on 1996-05-06 under 510(k) number K960624. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the CERTI COOL INSTANT COLD COMPRESS?

CERTI COOL INSTANT COLD COMPRESS is a medical device that received FDA 510(k) clearance on 1996-05-06. The listed applicant is Certified Safety Mfg., Inc.. The 510(k) number is K960624.

When did CERTI COOL INSTANT COLD COMPRESS receive FDA 510(k) clearance?

CERTI COOL INSTANT COLD COMPRESS received FDA 510(k) clearance on 1996-05-06, under 510(k) number K960624.

Who is the listed applicant for CERTI COOL INSTANT COLD COMPRESS?

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

What is the FDA product code for CERTI COOL INSTANT COLD COMPRESS?

The FDA product code for CERTI COOL INSTANT COLD COMPRESS is IMD.

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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.