SURGITEL
Spectacle, Operating (loupe), Ophthalmic
GENERAL SCIENTIFIC CORP.
The following data is part of a premarket notification filed by General Scientific Corp. with the FDA for Surgitel.
Pre-market Notification Details
| Device ID | K934494 |
| 510k Number | K934494 |
| Device Name: | SURGITEL |
| Classification | Spectacle, Operating (loupe), Ophthalmic |
| Applicant | GENERAL SCIENTIFIC CORP. 77 ENTERPRISE DR. Ann Arbor, MI 48103 |
| Contact | Harvey C Bauss |
| Correspondent | Harvey C Bauss GENERAL SCIENTIFIC CORP. 77 ENTERPRISE DR. Ann Arbor, MI 48103 |
| Product Code | HOH |
| CFR Regulation Number | 886.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-15 |
| Decision Date | 1994-01-25 |
Trademark Results [SURGITEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGITEL 97509737 not registered Live/Pending |
General Scientific Corporation 2022-07-19 |
 SURGITEL 74401769 1887834 Live/Registered |
General Scientific Corporation 1993-06-14 |
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