BIOBRANE BRAND TEMP. WOUND DRESSING W/ADHESIVE
FDA 510(k) clearance K844052 · decided 1985-01-23
Clearance details
- K-number
- K844052
- Device name
- BIOBRANE BRAND TEMP. WOUND DRESSING W/ADHESIVE
- Applicant
- Woodroof Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-18
- Decision date
- 1985-01-23
- Days to decision
- 97 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.