The following data is part of a premarket notification filed by Health Tec, Inc. with the FDA for Dry Comfort Undergarment.
| Device ID | K882418 |
| 510k Number | K882418 |
| Device Name: | DRY COMFORT UNDERGARMENT |
| Classification | Garment, Protective, For Incontinence |
| 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 | EYQ |
| CFR Regulation Number | 876.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-13 |
| Decision Date | 1988-09-29 |