FDA 510(k)

COOL CAST(R)

K-Number: K903946 · 1990-12-31

Decision Date1990-12-31

Product CodeLGF

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

COOL CAST(R) is the device name listed in this FDA 510(k) record. The listed applicant is Hawthorne Products, Inc.. It received FDA 510(k) clearance on 1990-12-31 under 510(k) number K903946. The device is classified under product code LGF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOL CAST(R)?

COOL CAST(R) is a medical device that received FDA 510(k) clearance on 1990-12-31. The listed applicant is Hawthorne Products, Inc.. The 510(k) number is K903946.

When did COOL CAST(R) receive FDA 510(k) clearance?

COOL CAST(R) received FDA 510(k) clearance on 1990-12-31, under 510(k) number K903946.

Who is the listed applicant for COOL CAST(R)?

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

What is the FDA product code for COOL CAST(R)?

The FDA product code for COOL CAST(R) is LGF.

Related Devices (Code: LGF)

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.

K043526SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATICNoble Fiber Technologies, Inc.K973420CLINITEX CAST PADDINGClinitex Medical Corp.K973417CLINITEX STOCKINETTEClinitex Medical Corp.K955320PROTEC COTTON PADDING BANDAGEDerivadas Degasa S.A. DE C.V.K932507QUICK-CAST IMMOBILIZERLandec Corp.K931672CARAPACE STERILE CAST PADDINGCarapace, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.