The following data is part of a premarket notification filed by Shanghai Jianzhong Medical Packaging Co., Ltd. with the FDA for Self Seal Sterilization Pouch.
| Device ID | K071886 |
| 510k Number | K071886 |
| Device Name: | SELF SEAL STERILIZATION POUCH |
| Classification | Wrap, Sterilization |
| Applicant | SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD. 1558-1-2101 SOUTH XIZANG ROAD Shanghai, CN 200011 |
| Contact | Longfu Song |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-07-09 |
| Decision Date | 2007-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20810132800232 | K071886 | 000 |
| 20810132800317 | K071886 | 000 |
| 20810132800331 | K071886 | 000 |
| 00810132800375 | K071886 | 000 |
| 20686864044783 | K071886 | 000 |
| 20686864044790 | K071886 | 000 |
| 20686864044806 | K071886 | 000 |
| 20686864044813 | K071886 | 000 |
| 20686864044820 | K071886 | 000 |
| 20686864044837 | K071886 | 000 |
| 20810132800300 | K071886 | 000 |
| 20810132800294 | K071886 | 000 |
| 20810132800256 | K071886 | 000 |
| 20810132800324 | K071886 | 000 |
| 20810132800348 | K071886 | 000 |
| 20810132800355 | K071886 | 000 |
| 20810132800362 | K071886 | 000 |
| 00810132800245 | K071886 | 000 |
| 00810132800269 | K071886 | 000 |
| 00810132800276 | K071886 | 000 |
| 00810132800283 | K071886 | 000 |
| 20686864044844 | K071886 | 000 |
| D883AA01403 | K071886 | 000 |
| D883AA01603 | K071886 | 000 |
| 20612479196586 | K071886 | 000 |
| 20612479196609 | K071886 | 000 |
| 20612479196623 | K071886 | 000 |
| 20612479196647 | K071886 | 000 |
| 20612479196661 | K071886 | 000 |
| 20612479203772 | K071886 | 000 |
| 20612479203796 | K071886 | 000 |
| 20612479203819 | K071886 | 000 |
| 20612479203833 | K071886 | 000 |
| 20612479196562 | K071886 | 000 |
| 20612479196548 | K071886 | 000 |
| D883AA01101 | K071886 | 000 |
| D883AA01111 | K071886 | 000 |
| D883AA01121 | K071886 | 000 |
| D883AA01131 | K071886 | 000 |
| D883AA01141 | K071886 | 000 |
| D883AA01151 | K071886 | 000 |
| D883AA01161 | K071886 | 000 |
| D883AA01171 | K071886 | 000 |
| D883AA01181 | K071886 | 000 |
| 20612479203857 | K071886 | 000 |