MICROTEK EQUIPMENT DRAPES
FDA 510(k) clearance K050322 · decided 2005-05-17
Clearance details
- K-number
- K050322
- Device name
- MICROTEK EQUIPMENT DRAPES
- Applicant
- Microtek Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-09
- Decision date
- 2005-05-17
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- KKX
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Columbus, MS, US
- Third-party review
- No
- Expedited review
- No
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