510(k) K020325

Device
L.A.M. IPM WOUND GEL
Applicant
L.A.M. PHARMACEUTICAL, CORP.
510(k) number
K020325
Product code
MGQ  
Decision
Substantially Equivalent (SESE)
Decision date
2002-04-15
Date received
2002-01-31
Regulation
510(k) Premarket Notification
Classification name
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
CLAWSON BOWMAN
Address
1330a Redwood Way Petaluma CA US 94954 94954

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MGQ  

510(k)DeviceApplicantDecision date
K171879HylaGuard Moisturizing CreamFounders Science Group, LLC2017-10-16
K083024HYLATOPIC EMOLLIENT FOAMCollegium Pharmaceutical Incorporated2009-03-27
K041342IMPRUV A.I. CREAM WOUND AND SKIN EMULSIONStiefel Laboratories, Inc.2005-07-19
K041268SILVERSITE OR CALGITROLAdri2004-09-20
K040019SILVERSEALNoble Fiber Technologies2004-07-23
K040517TENDERWET ACTIVEMedline Industries, Inc.2004-03-25
K022587MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGSMedtrade Products , Ltd.2003-08-22
K024367SINCLAIR WOUND AND SKIN EMULSIONSinclair Pharmaceuticals, Ltd.2003-07-28
K024054XYLOS XCELL ANTIMICROBIAL DRESSINGXylos Corporation2003-03-07
K022584CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSINGCardiotech Intl.2002-12-30
K022995COLLATEK HYDROGELBiocore Medical Technologies, Inc.2002-12-02
K013525CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)Coloplast Corp.2002-10-04
K011994ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101Acrymed, Inc.2001-11-08
K010583AMBU GEL, HYDROGEL BURN DRESSINGAmbu, Inc.2001-05-25
K002666DIAMOND ALOE VERA, STERILEMedi-Tech Intl. Corp.2001-02-27

Legacy Summary

summary

FDA Review

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