FDA 510(k)

HEMO-STAT

K-Number: K922636 · 1992-11-09

ApplicantMckinley-Ross Laboratories, Inc.

Decision Date1992-11-09

Product CodeSEJ

DecisionSubstantially Equivalent

Device Summary

HEMO-STAT is the device name listed in this FDA 510(k) record. The listed applicant is Mckinley-Ross Laboratories, Inc.. It received FDA 510(k) clearance on 1992-11-09 under 510(k) number K922636. The device is classified under product code SEJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMO-STAT?

HEMO-STAT is a medical device that received FDA 510(k) clearance on 1992-11-09. The listed applicant is Mckinley-Ross Laboratories, Inc.. The 510(k) number is K922636.

When did HEMO-STAT receive FDA 510(k) clearance?

HEMO-STAT received FDA 510(k) clearance on 1992-11-09, under 510(k) number K922636.

Who is the listed applicant for HEMO-STAT?

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

What is the FDA product code for HEMO-STAT?

The FDA product code for HEMO-STAT is SEJ.

Related Devices (Code: SEJ)

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.

K092086AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027Amerx Health Care Corp.K053476ALLWOUNDAt Squared, LLC K020540REGENECARE WOUND GELMpm Medical., Inc.K001023FREEDOM, MODEL 4660Johnson & Johnson Consumer Companies, Inc.K912565MICRO-COLL COLLAGEN WOUND SPRAYMicro-Coll

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.