GASTROTEC
FDA 510(k) clearance K954401 · decided 1996-04-25
Clearance details
- K-number
- K954401
- Device name
- GASTROTEC
- Applicant
- Patrick C. Jacobssen
- Decision
- Substantially Equivalent
- Date received
- 1995-09-20
- Decision date
- 1996-04-25
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- ESI
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Fairhope, AL, 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 |
|---|---|---|
| LM-150HT LIGHT SOURCE (K911212) | Leisegang Medical, Inc. | 1991-05-23 |
Recalls involving this device
No recalls on record reference this clearance.