The following data is part of a premarket notification filed by Copioumed Intl., Inc. with the FDA for Nurses Bouffant Cap.
| Device ID | K965237 |
| 510k Number | K965237 |
| Device Name: | NURSES BOUFFANT CAP |
| Classification | Accessory, Surgical Apparel |
| Applicant | COPIOUMED INTL., INC. 19001 S. RICHFIELD #185 Green Valley, AZ 85614 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker COPIOUMED INTL., INC. 19001 S. RICHFIELD #185 Green Valley, AZ 85614 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-31 |
| Decision Date | 1997-08-27 |