The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Spungard & Surg. Drapes-gowns & Packs.
| Device ID | K842115 |
| 510k Number | K842115 |
| Device Name: | SPUNGARD & SURG. DRAPES-GOWNS & PACKS |
| Classification | Drape, Surgical |
| Applicant | KIMBERLY-CLARK CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-25 |
| Decision Date | 1984-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651447631 | K842115 | 000 |
| 30680651900136 | K842115 | 000 |
| 30680651794346 | K842115 | 000 |
| 30680651794193 | K842115 | 000 |
| 30680651728884 | K842115 | 000 |
| 30680651728785 | K842115 | 000 |
| 30680651763823 | K842115 | 000 |
| 30680651790638 | K842115 | 000 |
| 30680651766817 | K842115 | 000 |
| 30680651795879 | K842115 | 000 |
| 30680651795770 | K842115 | 000 |
| 30680651795121 | K842115 | 000 |
| 30680651795114 | K842115 | 000 |
| 30680651900167 | K842115 | 000 |
| 30680651900198 | K842115 | 000 |
| 30680651900433 | K842115 | 000 |
| 30680651132292 | K842115 | 000 |
| 30680651796128 | K842115 | 000 |
| 30680651796111 | K842115 | 000 |
| 30680651729782 | K842115 | 000 |
| 30680651451829 | K842115 | 000 |
| 30680651952241 | K842115 | 000 |
| 30680651903731 | K842115 | 000 |
| 30680651903632 | K842115 | 000 |
| 30680651901430 | K842115 | 000 |
| 30680651901133 | K842115 | 000 |
| 30680651900495 | K842115 | 000 |
| 30680651900464 | K842115 | 000 |
| 30680651777769 | K842115 | 000 |