The following data is part of a premarket notification filed by Shenzhen Ant Hi-tech Industrial Co., Ltd with the FDA for Ant Inflation Device/ant Inflation Device Compact Pack.
| Device ID | K102648 |
| 510k Number | K102648 |
| Device Name: | ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK |
| Classification | Syringe, Balloon Inflation |
| Applicant | SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD BLDG 11 LISHAN INDUSTRIAL PARK XINGHAI AVE, NANSHAN DISTRICT Shenzhen, Guangdong, CN 518052 |
| Contact | Lynn Fu |
| Correspondent | Lynn Fu SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD BLDG 11 LISHAN INDUSTRIAL PARK XINGHAI AVE, NANSHAN DISTRICT Shenzhen, Guangdong, CN 518052 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-14 |
| Decision Date | 2011-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945764414059 | K102648 | 000 |
| 06945764414042 | K102648 | 000 |
| 06945764414035 | K102648 | 000 |