The following data is part of a premarket notification filed by Marco Ophthalmic, Inc. with the FDA for Marco Projection Perimeter.
Device ID | K930448 |
510k Number | K930448 |
Device Name: | MARCO PROJECTION PERIMETER |
Classification | Perimeter, Ac-powered |
Applicant | MARCO OPHTHALMIC, INC. 11825 CENTRAL PKWY. Jacksonville, FL 32224 |
Contact | Wayne Starling |
Correspondent | Wayne Starling MARCO OPHTHALMIC, INC. 11825 CENTRAL PKWY. Jacksonville, FL 32224 |
Product Code | HOO |
CFR Regulation Number | 886.1605 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-26 |
Decision Date | 1993-06-21 |