The following data is part of a premarket notification filed by Copioumed Intl., Inc. with the FDA for Isolation Gown.
| Device ID | K960999 |
| 510k Number | K960999 |
| Device Name: | ISOLATION GOWN |
| Classification | Gown, Isolation, Surgical |
| Applicant | COPIOUMED INTL., INC. 6F-1 NO. 169-12, SEC. 2 CHANG AN EAST ROAD Taipei, Taaaaiwan R.o.c., TW |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker COPIOUMED INTL., INC. 6F-1 NO. 169-12, SEC. 2 CHANG AN EAST ROAD Taipei, Taaaaiwan R.o.c., TW |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-12 |
| Decision Date | 1996-12-30 |