CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
FDA 510(k) clearance K171645 · decided 2017-07-25
Clearance details
- K-number
- K171645
- Device name
- CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
- Applicant
- Strukmyer Medical
- Decision
- Substantially Equivalent
- Date received
- 2017-06-05
- Decision date
- 2017-07-25
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- KGN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Mesquite, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Numbe recall (Z-1789-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-09-26 |