The following data is part of a premarket notification filed by Pms Tip Teknolojileri Sanayi Ve Ticaret Limited Std with the FDA for Pmssteripack Self-seal Sterilization Pouch With Chemical Indicator (kp).
| Device ID | K152669 |
| 510k Number | K152669 |
| Device Name: | PMSSteripack Self-Seal Sterilization Pouch With Chemical Indicator (KP) |
| Classification | Wrap, Sterilization |
| Applicant | PMS TIP TEKNOLOJILERI SANAYI VE TICARET LIMITED STD MERSIN TARSUS ORGANIZE SANAYI BOLGESI 12, CAD NO.2 HUZURKENT Mersin, TR 33020 |
| Contact | Derya Dikici |
| Correspondent | Derya Dikici PMS TIP TEKNOLOJILERI SANAYI VE TICARET LIMITED STD MERSIN TARSUS ORGANIZE SANAYI BOLGESI 12, CAD NO.2 HUZURKENT 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 | 2015-09-17 |
| Decision Date | 2016-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814434020701 | K152669 | 000 |
| 10850144008014 | K152669 | 000 |
| 10850144008021 | K152669 | 000 |
| 10850144008038 | K152669 | 000 |
| 00850144008048 | K152669 | 000 |
| 10850144008052 | K152669 | 000 |
| 00850144008062 | K152669 | 000 |
| 00850144008079 | K152669 | 000 |
| 20814434020619 | K152669 | 000 |
| 20814434020626 | K152669 | 000 |
| 00814434020639 | K152669 | 000 |
| 20814434020640 | K152669 | 000 |
| 20814434020657 | K152669 | 000 |
| 20814434020664 | K152669 | 000 |
| 20814434020671 | K152669 | 000 |
| 20814434020688 | K152669 | 000 |
| 20814434020695 | K152669 | 000 |
| 10850144008007 | K152669 | 000 |