The following data is part of a premarket notification filed by Pms Medikal Ambalaj Sanayi Ve Ticaret Ltd Sti with the FDA for Pmssteripack Tyvek Sterilization Pouch (tp) And Roll (ty) With Chemical Indicator.
| Device ID | K160595 |
| 510k Number | K160595 |
| Device Name: | PMSSteripack Tyvek Sterilization Pouch (TP) And Roll (TY) With Chemical Indicator |
| Classification | Wrap, Sterilization |
| Applicant | PMS Medikal Ambalaj Sanayi Ve Ticaret LTD STI Karaduvar Mah Serbest Bolge, 11 Cad, No. 46, Mersin Serbest Bolgesi, Akdeniz Mersin, TR 33020 |
| Contact | Derya Dikici |
| Correspondent | Derya Dikici PMS Medikal Ambalaj Sanayi Ve Ticaret LTD STI 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 | 2016-03-01 |
| Decision Date | 2016-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850144008208 | K160595 | 000 |
| 00850144008093 | K160595 | 000 |
| 00850144008109 | K160595 | 000 |
| 00850144008116 | K160595 | 000 |
| 10850144008120 | K160595 | 000 |
| 00850144008130 | K160595 | 000 |
| 00850144008147 | K160595 | 000 |
| 00850144008154 | K160595 | 000 |
| 00850144008161 | K160595 | 000 |
| 00850144008178 | K160595 | 000 |
| 00850144008185 | K160595 | 000 |
| 00850144008192 | K160595 | 000 |
| 10850144008083 | K160595 | 000 |