AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027
FDA 510(k) clearance K092086 · decided 2009-07-30
Clearance details
- K-number
- K092086
- Device name
- AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027
- Applicant
- Amerx Health Care Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-09
- Decision date
- 2009-07-30
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- SEJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ALLWOUND (K053476) | At Squared, LLC | 2006-06-26 |
| REGENECARE WOUND GEL (K020540) | Mpm Medical., Inc. | 2002-11-01 |
| FREEDOM, MODEL 4660 (K001023) | Johnson & Johnson Consumer Companies, Inc. | 2000-09-22 |
| HEMO-STAT (K922636) | Mckinley-Ross Laboratories, Inc. | 1992-11-09 |
| MICRO-COLL COLLAGEN WOUND SPRAY (K912565) | Micro-Coll | 1992-06-11 |
Recalls involving this device
No recalls on record reference this clearance.