The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Ultra Surgical Gown & Fluid Barrier Surgical Gown.
| Device ID | K080795 |
| 510k Number | K080795 |
| Device Name: | ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN |
| Classification | Gown, Surgical |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. BLDG 300, #1092 Roswell, GA 30076 -2199 |
| Contact | David M Lee |
| Correspondent | David M Lee KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. BLDG 300, #1092 Roswell, GA 30076 -2199 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-20 |
| Decision Date | 2008-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651765315 | K080795 | 000 |
| 30680651951312 | K080795 | 000 |
| 30680651951213 | K080795 | 000 |
| 30680651951114 | K080795 | 000 |
| 30680651951015 | K080795 | 000 |
| 30680651397158 | K080795 | 000 |
| 30680651397134 | K080795 | 000 |
| 30680651337062 | K080795 | 000 |
| 30680651337055 | K080795 | 000 |
| 30680651337048 | K080795 | 000 |
| 30680651337031 | K080795 | 000 |
| 30680651741166 | K080795 | 000 |
| 30680651741159 | K080795 | 000 |
| 30680651954115 | K080795 | 000 |
| 10680651954210 | K080795 | 000 |
| 30680651765117 | K080795 | 000 |
| 30680651744211 | K080795 | 000 |
| 30680651744112 | K080795 | 000 |
| 30680651716270 | K080795 | 000 |
| 30680651716263 | K080795 | 000 |
| 30680651713316 | K080795 | 000 |
| 30680651713217 | K080795 | 000 |
| 30680651713118 | K080795 | 000 |
| 30680651713019 | K080795 | 000 |
| 30680651955310 | K080795 | 000 |
| 10680651955118 | K080795 | 000 |
| 10680651954319 | K080795 | 000 |
| 30680651132346 | K080795 | 000 |