The following data is part of a premarket notification filed by Devon Medical Inc. with the FDA for Extricare.
Device ID | K132225 |
510k Number | K132225 |
Device Name: | EXTRICARE |
Classification | Negative Pressure Wound Therapy Powered Suction Pump |
Applicant | DEVON MEDICAL INC. 1100 FIRST AVE, STE 202 King Of Prussia, PA 19406 |
Contact | Ruth Wu |
Correspondent | Ruth Wu DEVON MEDICAL INC. 1100 FIRST AVE, STE 202 King Of Prussia, PA 19406 |
Product Code | OMP |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-17 |
Decision Date | 2014-05-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10879766005843 | K132225 | 000 |
10879766005836 | K132225 | 000 |
10879766005829 | K132225 | 000 |
10879766005676 | K132225 | 000 |
10879766005669 | K132225 | 000 |
10879766005560 | K132225 | 000 |
10879766005553 | K132225 | 000 |
10879766005478 | K132225 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EXTRICARE 88673767 not registered Live/Pending |
Alleva Medical Limited 2019-10-30 |
EXTRICARE 85409036 4280461 Dead/Cancelled |
MEDU-SCIENTIFIC LIMITED 2011-08-27 |