The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Guardian Peel Pouches.
| Device ID | K803293 |
| 510k Number | K803293 |
| Device Name: | GUARDIAN PEEL POUCHES |
| Classification | Wrap, Sterilization |
| Applicant | KIMBERLY-CLARK CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-30 |
| Decision Date | 1981-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438263620187 | K803293 | 000 |
| 06438263620170 | K803293 | 000 |
| 06438263620163 | K803293 | 000 |
| 06438263620156 | K803293 | 000 |
| 06438263620149 | K803293 | 000 |
| 06438263620132 | K803293 | 000 |
| 06438263620125 | K803293 | 000 |
| 06438263620118 | K803293 | 000 |