The following data is part of a premarket notification filed by Schering-plough Healthcare Products, Inc. with the FDA for Dr. Scholl's Dual Action Freeze Away Wart Remover, Model 40406.
| Device ID | K052259 |
| 510k Number | K052259 |
| Device Name: | DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC. 3 CONNELL DR. Berkeley Heights, NJ 07922 -0603 |
| Contact | Doreen Frank |
| Correspondent | Doreen Frank SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC. 3 CONNELL DR. Berkeley Heights, NJ 07922 -0603 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-08-19 |
| Decision Date | 2005-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10311017405304 | K052259 | 000 |
| 10888853000135 | K052259 | 000 |
| 00888853000114 | K052259 | 000 |
| 10888853000050 | K052259 | 000 |