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 |