The following data is part of a premarket notification filed by Marco Ophthalmic, Inc. with the FDA for Marco Models G,h And Primary Care Slit Lamps.
| Device ID | K930438 |
| 510k Number | K930438 |
| Device Name: | MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS |
| Classification | Biomicroscope, Slit-lamp, 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 | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-26 |
| Decision Date | 1993-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06909071671222 | K930438 | 000 |
| 06909071671215 | K930438 | 000 |
| 06909071671192 | K930438 | 000 |
| 06909071671185 | K930438 | 000 |
| 06909071671178 | K930438 | 000 |
| 06909071671161 | K930438 | 000 |