The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Microcool Surgical Gown.
| Device ID | K981393 |
| 510k Number | K981393 |
| Device Name: | MICROCOOL SURGICAL GOWN |
| Classification | Gown, Surgical |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Larry R Kludt |
| Correspondent | Larry R Kludt KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-17 |
| Decision Date | 1998-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651780424 | K981393 | 000 |
| 30680651780127 | K981393 | 000 |