The following data is part of a premarket notification filed by Pms Tibbi Cihazlar Teknolojisi San Ve Tic As with the FDA for Pmssteripack Flat Sterilization Pouch (fp) And Roll (fl) With Chemical Indicator.
| Device ID | K162362 |
| 510k Number | K162362 |
| Device Name: | PMSSteripack Flat Sterilization Pouch (FP) And Roll (FL) With Chemical Indicator |
| Classification | Wrap, Sterilization |
| Applicant | PMS TIBBI CIHAZLAR TEKNOLOJISI SAN VE TIC AS KARADUVAR MAH.SERBEST BOLGE, 11.CAD NO.46 MERSIN SERBEST BOLGESI, AKDENIZ Mersin, TR 33020 |
| Contact | Derya Dikici |
| Correspondent | Derya Dikici PMS TIBBI CIHAZLAR TEKNOLOJISI SAN VE TIC AS KARADUVAR MAH.SERBEST BOLGE, 11.CAD NO.46 MERSIN SERBEST BOLGESI, AKDENIZ Mersin, TR 33020 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-23 |
| Decision Date | 2017-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850144008710 | K162362 | 000 |
| 00850144008345 | K162362 | 000 |
| 00850144008321 | K162362 | 000 |
| 00850144008291 | K162362 | 000 |
| 10850144008267 | K162362 | 000 |
| 00850144008246 | K162362 | 000 |
| 00850144008215 | K162362 | 000 |
| 00850144008840 | K162362 | 000 |
| 00850144008871 | K162362 | 000 |
| 00850144008864 | K162362 | 000 |
| 00850144008376 | K162362 | 000 |
| 00850144008406 | K162362 | 000 |
| 00850144008437 | K162362 | 000 |
| 00850144008680 | K162362 | 000 |
| 00850144008659 | K162362 | 000 |
| 00850144008628 | K162362 | 000 |
| 00850144008598 | K162362 | 000 |
| 00850144008567 | K162362 | 000 |
| 00850144008543 | K162362 | 000 |
| 00850144008512 | K162362 | 000 |
| 00850144008482 | K162362 | 000 |
| 00850144008468 | K162362 | 000 |
| 00850144008857 | K162362 | 000 |