The following data is part of a premarket notification filed by Hk Surgical, Inc. with the FDA for Hk Liposuction Aspirator, Model Ap-iii & Ap230-iii.
Device ID | K032802 |
510k Number | K032802 |
Device Name: | HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III |
Classification | System, Suction, Lipoplasty |
Applicant | HK SURGICAL, INC. 2620A TEMPLE HEIGHTS DR. Oceanside, CA 92675 |
Contact | Sally M Bowdon |
Correspondent | Sally M Bowdon HK SURGICAL, INC. 2620A TEMPLE HEIGHTS DR. Oceanside, CA 92675 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-09 |
Decision Date | 2003-11-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08169890200166 | K032802 | 000 |
08169890200159 | K032802 | 000 |