The following data is part of a premarket notification filed by Aplicare, Inc. with the FDA for Aplicare Skin Protectant Swabstick.
| Device ID | K861558 |
| 510k Number | K861558 |
| Device Name: | APLICARE SKIN PROTECTANT SWABSTICK |
| Classification | Bandage, Liquid, Skin Protectant |
| Applicant | APLICARE, INC. 7 ORCHARD PARK RD. Madison, CT 06443 |
| Contact | Paul G Buccetti |
| Correspondent | Paul G Buccetti APLICARE, INC. 7 ORCHARD PARK RD. Madison, CT 06443 |
| Product Code | NEC |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-25 |
| Decision Date | 1986-06-04 |