The following data is part of a premarket notification filed by Ding Hwa Co., Ltd. with the FDA for Cliq Dv-300 Aspirator.
Device ID | K132308 |
510k Number | K132308 |
Device Name: | CLIQ DV-300 ASPIRATOR |
Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
Applicant | DING HWA CO., LTD. 1083 DELAWARE AVENUE Buffalo, NY 14209 |
Contact | Robert O Dean |
Correspondent | Robert O Dean DING HWA CO., LTD. 1083 DELAWARE AVENUE Buffalo, NY 14209 |
Product Code | JCX |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-25 |
Decision Date | 2013-12-30 |
Summary: | summary |