The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Integuseal Microbial Sealant, Model Is 100 And 1s200.
| Device ID | K052870 |
| 510k Number | K052870 |
| Device Name: | INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 |
| Classification | Sealant, Microbial |
| Applicant | KIMBERLY-CLARK CORP. 5353 WAYZATA BLVD., SUITE 505 Minneapolis, MN 55416 -1334 |
| Contact | Tierney Norsted |
| Correspondent | Tierney Norsted KIMBERLY-CLARK CORP. 5353 WAYZATA BLVD., SUITE 505 Minneapolis, MN 55416 -1334 |
| Product Code | NZP |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-11 |
| Decision Date | 2006-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193494337374 | K052870 | 000 |
| 20193494337364 | K052870 | 000 |