ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
FDA 510(k) clearance K063582 · decided 2007-04-26
Clearance details
- K-number
- K063582
- Device name
- ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-01
- Decision date
- 2007-04-26
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dover, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
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