The following data is part of a premarket notification filed by Ophthalmic Technologies, Inc. with the FDA for Di-rhex Ophthalmic Diathermy System.
Device ID | K990064 |
510k Number | K990064 |
Device Name: | DI-RHEX OPHTHALMIC DIATHERMY SYSTEM |
Classification | Apparatus, Cautery, Radiofrequency, Ac-powered |
Applicant | OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario, CA Mej 3e5 |
Contact | George Myers |
Correspondent | George Myers OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario, CA Mej 3e5 |
Product Code | HQR |
CFR Regulation Number | 886.4100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-01-08 |
Decision Date | 1999-04-04 |
Summary: | summary |