ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-
FDA 510(k) clearance K992769 · decided 1999-10-14
Clearance details
- K-number
- K992769
- Device name
- ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-
- Applicant
- Erbe USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-08-17
- Decision date
- 1999-10-14
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.