GUARDIAN GEL, SURGEON'S GLOVING CREAM
FDA 510(k) clearance K910687 · decided 1991-10-11
Clearance details
- K-number
- K910687
- Device name
- GUARDIAN GEL, SURGEON'S GLOVING CREAM
- Applicant
- Guardian Angel Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-02-19
- Decision date
- 1991-10-11
- Days to decision
- 234 days
- Clearance type
- Traditional
- Product code
- KGQ
- Device class
- 1
- Regulation number
- 878.4470
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.