REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE
FDA 510(k) clearance K980516 · decided 1998-04-23
Clearance details
- K-number
- K980516
- Device name
- REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE
- Applicant
- London International Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-10
- Decision date
- 1998-04-23
- Days to decision
- 72 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
- Dotham, AL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.