The following data is part of a premarket notification filed by Chicopee, Inc. with the FDA for Chicopee Adult Incontinence Shields.
| Device ID | K880338 |
| 510k Number | K880338 |
| Device Name: | CHICOPEE ADULT INCONTINENCE SHIELDS |
| Classification | Garment, Protective, For Incontinence |
| Applicant | CHICOPEE, INC. 2351 U.S. RT. 130 P.O. BOX 940 Dayton, NJ 08810 |
| Contact | Stanley L Burd |
| Correspondent | Stanley L Burd CHICOPEE, INC. 2351 U.S. RT. 130 P.O. BOX 940 Dayton, NJ 08810 |
| Product Code | EYQ |
| CFR Regulation Number | 876.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-03-31 |