510(k) K022584
- Device
- CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING
- Applicant
- CARDIOTECH INTL.
- 510(k) number
- K022584
- Product code
- MGQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-12-30
- Date received
- 2002-08-05
- 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
- ANDREW M REED
- Address
- 12106 W. 75th Ln. Arvada CO US 80005 80005
FDA Registration Numbers
- 1038758
- 3006052875
- 9680091
- 1423537
- 2029275
- 3009882464
- 1063707
- 1058584
- 3012535730
- 1219103
- 2320762
- 1043214
- 9610200
- 3003636207
- 3024971708
- 3011276993
- 3015528146
- 3007289408
- 3005465238
- 1921846
- 3010143501
- 3023548698
- 2125337
- 3005761322
- 1055236
- 3013298431
- 3005689226
- 3007048057
- 1417592
- 1646434
- 3014579161
- 3006784948
- 3012979524
- 3012263097
- 1649690
- 1036836
- 1018120
- 2135152
- 9610694
- 1649518
- 1034876
- 3016096134
- 3008770963
- 3016761372
- 1419520
- 1219592
- 3013557562
- 1054241
- 3005488444
- 3010315629
- 1061124
- 2132242
- 8044046
- 9680143
- 3010287685
Source Documents
Other 510(k) Records For Product Code MGQ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171879 | HylaGuard Moisturizing Cream | Founders Science Group, LLC | 2017-10-16 |
| K083024 | HYLATOPIC EMOLLIENT FOAM | Collegium Pharmaceutical Incorporated | 2009-03-27 |
| K041342 | IMPRUV A.I. CREAM WOUND AND SKIN EMULSION | Stiefel Laboratories, Inc. | 2005-07-19 |
| K041268 | SILVERSITE OR CALGITROL | Adri | 2004-09-20 |
| K040019 | SILVERSEAL | Noble Fiber Technologies | 2004-07-23 |
| K040517 | TENDERWET ACTIVE | Medline Industries, Inc. | 2004-03-25 |
| K022587 | MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS | Medtrade Products , Ltd. | 2003-08-22 |
| K024367 | SINCLAIR WOUND AND SKIN EMULSION | Sinclair Pharmaceuticals, Ltd. | 2003-07-28 |
| K024054 | XYLOS XCELL ANTIMICROBIAL DRESSING | Xylos Corporation | 2003-03-07 |
| K022995 | COLLATEK HYDROGEL | Biocore Medical Technologies, Inc. | 2002-12-02 |
| K013525 | CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) | Coloplast Corp. | 2002-10-04 |
| K020325 | L.A.M. IPM WOUND GEL | L.A.M. Pharmaceutical, Corp. | 2002-04-15 |
| K011994 | ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 | Acrymed, Inc. | 2001-11-08 |
| K010583 | AMBU GEL, HYDROGEL BURN DRESSING | Ambu, Inc. | 2001-05-25 |
| K002666 | DIAMOND ALOE VERA, STERILE | Medi-Tech Intl. Corp. | 2001-02-27 |
Legacy Summary
summary
FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases