510(k) K954401
- Device
- GASTROTEC
- Applicant
- PATRICK C. JACOBSSEN
- 510(k) number
- K954401
- Product code
- ESI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-25
- Date received
- 1995-09-20
- Regulation
- 510(k) Premarket Notification
- Classification name
- Polymer, Natural-absorbable Gelatin Material
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Ear Nose & Throat
- Device class
- 3
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICK C JACOBSSEN
- Address
- 19730 Huntrs Loop Fairhope AL US 36532 36532
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ESI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K911212 | LM-150HT LIGHT SOURCE | Leisegang Medical, Inc. | 1991-05-23 |
Legacy Summary#
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FDA Review#
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