The following data is part of a premarket notification filed by Sci-pharm Scientific Pharmaceutical, Inc. with the FDA for Glasion Varnish.
| Device ID | K915376 |
| 510k Number | K915376 |
| Device Name: | GLASION VARNISH |
| Classification | Patient Examination Glove |
| Applicant | SCI-PHARM SCIENTIFIC PHARMACEUTICAL, INC. 3221 PRODUCER WAY Pomona, CA 91768 |
| Contact | Jan Orlowski |
| Correspondent | Jan Orlowski SCI-PHARM SCIENTIFIC PHARMACEUTICAL, INC. 3221 PRODUCER WAY Pomona, CA 91768 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-29 |
| Decision Date | 1992-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D801SP50311 | K915376 | 000 |
| D801SP5003S1 | K915376 | 000 |
| D801SP500321 | K915376 | 000 |
| D801SP500311 | K915376 | 000 |