The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Sci-pharm Dfv Varnish.
| Device ID | K982915 |
| 510k Number | K982915 |
| Device Name: | SCI-PHARM DFV VARNISH |
| Classification | Varnish, Cavity |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 3221 PRODUCER WAY Pomona, CA 91768 -3916 |
| Contact | Jan A Orlowski |
| Correspondent | Jan A Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 3221 PRODUCER WAY Pomona, CA 91768 -3916 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-19 |
| Decision Date | 1999-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D687AD311022 | K982915 | 000 |
| D687AD311012 | K982915 | 000 |
| D796710200 | K982915 | 000 |
| D79671011 | K982915 | 000 |
| D79671001 | K982915 | 000 |