The following data is part of a premarket notification filed by Marco Ophthalmic, Inc. with the FDA for Ms-30 Automatic Perimeter.
Device ID | K943234 |
510k Number | K943234 |
Device Name: | MS-30 AUTOMATIC PERIMETER |
Classification | Perimeter, Automatic, Ac-powered |
Applicant | MARCO OPHTHALMIC, INC. 11825 CENTRAL PKWY. Jacksonville, FL 32224 |
Contact | Joe T Lumpkin, Jr. |
Correspondent | Joe T Lumpkin, Jr. MARCO OPHTHALMIC, INC. 11825 CENTRAL PKWY. Jacksonville, FL 32224 |
Product Code | HPT |
CFR Regulation Number | 886.1605 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-06 |
Decision Date | 1994-07-27 |