The following data is part of a premarket notification filed by Oclassen Pharmaceuticals, Inc. with the FDA for Iodoflex Paste.
| Device ID | K940414 |
| 510k Number | K940414 |
| Device Name: | IODOFLEX PASTE |
| Classification | Bandage, Liquid |
| Applicant | OCLASSEN PHARMACEUTICALS, INC. 100 PELICAN WAY San Rafael, CA 94901 |
| Contact | Ross J Dileo |
| Correspondent | Ross J Dileo OCLASSEN PHARMACEUTICALS, INC. 100 PELICAN WAY San Rafael, CA 94901 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-28 |
| Decision Date | 1994-04-28 |