The following data is part of a premarket notification filed by Johnson & Johnson Consumer Products, Inc. with the FDA for Bengay (r) Heat Therapy, Pain Relieving Patches/pads (various).
| Device ID | K071710 |
| 510k Number | K071710 |
| Device Name: | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. 201 TABOR ROAD Morris Plains, NJ 07950 |
| Contact | Dagmar Oette |
| Correspondent | Dagmar Oette JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. 201 TABOR ROAD Morris Plains, NJ 07950 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-22 |
| Decision Date | 2007-08-14 |
| Summary: | summary |