The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Bouffant-style Surgical Cap.
| Device ID | K863359 |
| 510k Number | K863359 |
| Device Name: | BOUFFANT-STYLE SURGICAL CAP |
| Classification | Cap, Surgical |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Cynthia Smith |
| Correspondent | Cynthia Smith KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | FYF |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-02 |
| Decision Date | 1986-09-29 |