The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Spunguard Plus Surgical Drape.
| Device ID | K862801 |
| 510k Number | K862801 |
| Device Name: | SPUNGUARD PLUS SURGICAL DRAPE |
| Classification | Drape, Surgical |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Cynthia E Smith |
| Correspondent | Cynthia E Smith KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-23 |
| Decision Date | 1986-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50749756356249 | K862801 | 000 |
| 50749756356232 | K862801 | 000 |