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FDA 510(k)

BASIN PACK

K-Number: K802538 · 1980-10-31

ApplicantTexas Medical Products, Inc.
Decision Date1980-10-31
Product CodeFNY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BASIN PACK is the device name listed in this FDA 510(k) record. The listed applicant is Texas Medical Products, Inc.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802538. The device is classified under product code FNY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BASIN PACK?

BASIN PACK is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Texas Medical Products, Inc.. The 510(k) number is K802538.

When did BASIN PACK receive FDA 510(k) clearance?

BASIN PACK received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802538.

Who is the listed applicant for BASIN PACK?

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

What is the FDA product code for BASIN PACK?

The FDA product code for BASIN PACK is FNY.

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Other records listing Texas Medical Products, Inc. as applicant

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Related Devices (Code: FNY)

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.

K832826AAP DOSIMETRY RELEASE OR BASIN SETSAmerican Hospital Supply Corp.K800440STERILE SPONGE BOWLSPremium Plastics, Inc.K792625STERILIZATION PROCESS/PLACENTA BASINProcter & Gamble Mfg. Co.K7717338 EMESIS BASINBemis Health CareK760494BASIN, ROUND WASHLandmark PlasticsK760495BASIN, RECTANGULAR WASHLandmark Plastics

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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