The following data is part of a premarket notification filed by Avon Products, Inc. with the FDA for Hand-held Heat Applicator.
| Device ID | K935995 |
| 510k Number | K935995 |
| Device Name: | HAND-HELD HEAT APPLICATOR |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | AVON PRODUCTS, INC. ONE ASTOR PLAZA 1515 BROADWAY, 43RD FLOOR New York, NY 10036 -8901 |
| Contact | David A Eisen |
| Correspondent | David A Eisen AVON PRODUCTS, INC. ONE ASTOR PLAZA 1515 BROADWAY, 43RD FLOOR New York, NY 10036 -8901 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-15 |
| Decision Date | 1994-06-09 |