The following data is part of a premarket notification filed by Medical Device Resource Corp. with the FDA for Power Aspirator, Model Ls2 Or Ls2dp.
Device ID | K081593 |
510k Number | K081593 |
Device Name: | POWER ASPIRATOR, MODEL LS2 OR LS2DP |
Classification | System, Suction, Lipoplasty |
Applicant | MEDICAL DEVICE RESOURCE CORP. 23392 CONNECTICUT ST. Hayward, CA 94545 |
Contact | Mel Kimsey |
Correspondent | Mel Kimsey MEDICAL DEVICE RESOURCE CORP. 23392 CONNECTICUT ST. Hayward, CA 94545 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-06 |
Decision Date | 2008-07-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00859898006416 | K081593 | 000 |
00859898006379 | K081593 | 000 |
00859898006256 | K081593 | 000 |
10859898006505 | K081593 | 000 |
00859898006492 | K081593 | 000 |