The following data is part of a premarket notification filed by Micro Media Laboratories with the FDA for 0.85% Saline.
| Device ID | K850845 |
| 510k Number | K850845 |
| Device Name: | 0.85% SALINE |
| Classification | General Purpose Reagent |
| Applicant | MICRO MEDIA LABORATORIES 2775 KURTZ SAN DIEGO, CA 92110 |
| Contact | PETER G MARTIN |
| Correspondent | PETER G MARTIN MICRO MEDIA LABORATORIES 2775 KURTZ SAN DIEGO, CA 92110 |
| Product Code | PPM |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1985-03-20 |