The following data is part of a premarket notification filed by Home Healthcare Products, Inc. with the FDA for Dunlap Heat Pad.
| Device ID | K911195 |
| 510k Number | K911195 |
| Device Name: | DUNLAP HEAT PAD |
| Classification | Pad, Heating, Powered |
| Applicant | HOME HEALTHCARE PRODUCTS, INC. C/O NTL ASSOCIATES, INC. 29 AINSWORTH AVENUE East Brunswick, NJ 08816 |
| Contact | Eric Flam |
| Correspondent | Eric Flam HOME HEALTHCARE PRODUCTS, INC. C/O NTL ASSOCIATES, INC. 29 AINSWORTH AVENUE East Brunswick, NJ 08816 |
| Product Code | IRT |
| CFR Regulation Number | 890.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-18 |
| Decision Date | 1991-08-12 |