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FDA 510(k)

REGENECARE WOUND GEL

K-Number: K020540 · 2002-11-01

ApplicantMpm Medical., Inc.
Decision Date2002-11-01
Product CodeSEJ
DecisionSubstantially Equivalent

Device Summary

REGENECARE WOUND GEL is the device name listed in this FDA 510(k) record. The listed applicant is Mpm Medical., Inc.. It received FDA 510(k) clearance on 2002-11-01 under 510(k) number K020540. The device is classified under product code SEJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGENECARE WOUND GEL?

REGENECARE WOUND GEL is a medical device that received FDA 510(k) clearance on 2002-11-01. The listed applicant is Mpm Medical., Inc.. The 510(k) number is K020540.

When did REGENECARE WOUND GEL receive FDA 510(k) clearance?

REGENECARE WOUND GEL received FDA 510(k) clearance on 2002-11-01, under 510(k) number K020540.

Who is the listed applicant for REGENECARE WOUND GEL?

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

What is the FDA product code for REGENECARE WOUND GEL?

The FDA product code for REGENECARE WOUND GEL is SEJ.

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Other records listing Mpm Medical., Inc. as applicant

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.

K060340ORAMAGIC PLUS ORAL WOUND RINSEK024180ORAMAGICRX ORAL WOUND RINSEK992074MPM REGENECARE WOUND GELK962160MPM HYDROGEL DRESSING (NON-STERILE)K952276MPM HYDROGEL DRESSINGK942798MPM HYDROGEL

View all 9 devices →

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, LLCK001023FREEDOM, MODEL 4660Johnson & Johnson Consumer Companies, Inc.K922636HEMO-STATMckinley-Ross Laboratories, Inc.K912565MICRO-COLL COLLAGEN WOUND SPRAYMicro-Coll

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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