The following data is part of a premarket notification filed by Sunny Medical Device (shenzhen) Co., Ltd with the FDA for Summed Inflation Device Kit.
| Device ID | K133795 |
| 510k Number | K133795 |
| Device Name: | SUMMED INFLATION DEVICE KIT |
| Classification | Syringe, Balloon Inflation |
| Applicant | SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD 56 LEHIGH AISLE Irvine, CA 92612 |
| Contact | James Qi Zhang |
| Correspondent | James Qi Zhang SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD 56 LEHIGH AISLE Irvine, CA 92612 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-13 |
| Decision Date | 2014-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06947358563006 | K133795 | 000 |
| 06947358563402 | K133795 | 000 |