XTRACETEZE SURGICAL SKIN STAPLE REMOVER 2001
FDA 510(k) clearance K844110 · decided 1984-11-19
Clearance details
- K-number
- K844110
- Device name
- XTRACETEZE SURGICAL SKIN STAPLE REMOVER 2001
- Applicant
- Pelco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-23
- Decision date
- 1984-11-19
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- PYE
- Device class
- 1
- Regulation number
- 878.4760
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Annapolis, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.