510(k) K911212
- Device
- LM-150HT LIGHT SOURCE
- Applicant
- LEISEGANG MEDICAL, INC.
- 510(k) number
- K911212
- Product code
- ESI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-05-23
- Date received
- 1991-03-19
- 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
- Third party reviewed
- No
Applicant Contact#
- Contact
- DOUGLAS DWART
- Address
- 6401 Congress Ave. Boca Raton FL US 33487 33487
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ESI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954401 | GASTROTEC | Patrick C. Jacobssen | 1996-04-25 |
Legacy Summary#
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FDA Review#
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