The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Full Coverage Hood.
Device ID | K875261 |
510k Number | K875261 |
Device Name: | KIMBERLY-CLARK FULL COVERAGE HOOD |
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 | 1987-12-21 |
Decision Date | 1988-01-22 |