The following data is part of a premarket notification filed by Advanced Medical Solutions (plymouth) Ltd with the FDA for Liquidband Flow Control.
Device ID | K122446 |
510k Number | K122446 |
Device Name: | LIQUIDBAND FLOW CONTROL |
Classification | Tissue Adhesive For The Topical Approximation Of Skin |
Applicant | ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD WESTERN WOOD WAY LANAGAGE SCIENCE PARK Plymouth, GB Pl7 5bg |
Contact | Michael Browne |
Correspondent | Michael Browne ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD WESTERN WOOD WAY LANAGAGE SCIENCE PARK Plymouth, GB Pl7 5bg |
Product Code | MPN |
CFR Regulation Number | 878.4010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-08-10 |
Decision Date | 2012-10-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05036912000970 | K122446 | 000 |
05036912000406 | K122446 | 000 |
50885380109780 | K122446 | 000 |
50885380109766 | K122446 | 000 |
30884521196777 | K122446 | 000 |