MEC-1 VIDEO COMBO SYSTEM
FDA 510(k) clearance K883944 · decided 1988-09-28
Clearance details
- K-number
- K883944
- Device name
- MEC-1 VIDEO COMBO SYSTEM
- Applicant
- Medical Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-19
- Decision date
- 1988-09-28
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- FTS
- Device class
- 1
- Regulation number
- 878.4160
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Santa Barbara, CA, 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.
| Record | Firm | Date |
|---|---|---|
| CCM-1 VIDEO CAMERA SYSTEM (K883943) | Medical Concepts, Inc. | 1988-09-28 |
Recalls involving this device
No recalls on record reference this clearance.