The following data is part of a premarket notification filed by Guardian Chemical with the FDA for Skin-lite.
| Device ID | K843300 |
| 510k Number | K843300 |
| Device Name: | SKIN-LITE |
| Classification | Bandage, Liquid |
| Applicant | GUARDIAN CHEMICAL P.O. BOX 2500 Smithtown, NY 11787 |
| Contact | Robert S Rubinger |
| Correspondent | Robert S Rubinger GUARDIAN CHEMICAL P.O. BOX 2500 Smithtown, NY 11787 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-23 |
| Decision Date | 1984-11-07 |