MICROSCRAPE
FDA 510(k) clearance K881151 · decided 1988-04-06
Clearance details
- K-number
- K881151
- Device name
- MICROSCRAPE
- Applicant
- Ortho Pharmaceutical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-17
- Decision date
- 1988-04-06
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- LXK
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Raritan, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.