The following data is part of a premarket notification filed by Health Tec, Inc. with the FDA for Dry Comfort Disposable Underpad.
| Device ID | K881969 |
| 510k Number | K881969 |
| Device Name: | DRY COMFORT DISPOSABLE UNDERPAD |
| Classification | Bedding, Disposable, Medical |
| Applicant | HEALTH TEC, INC. FIRST ST. Palmer, MA 01069 |
| Contact | Anthony Hay |
| Correspondent | Anthony Hay HEALTH TEC, INC. FIRST ST. Palmer, MA 01069 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-11 |
| Decision Date | 1988-06-07 |