DERMASTREAM
FDA 510(k) clearance K060046 · decided 2006-02-27
Clearance details
- K-number
- K060046
- Device name
- DERMASTREAM
- Applicant
- Enzysurge , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-06
- Decision date
- 2006-02-27
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- NAD
- Device class
- 1
- Regulation number
- 878.4020
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Somerset, MA, US
- Third-party review
- No
- Expedited review
- No
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| DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL (K960815) | Dumex Medical Surgical Products, Ltd. | 1996-04-29 |
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| OTOSILK (K952203) | Boston Medical Products, Inc. | 1995-07-31 |
Recalls involving this device
No recalls on record reference this clearance.