The following data is part of a premarket notification filed by Covidien Llc with the FDA for Permacol Surgical Implant.
Device ID | K120605 |
510k Number | K120605 |
Device Name: | PERMACOL SURGICAL IMPLANT |
Classification | Mesh, Surgical |
Applicant | Covidien LLC 15 CROSBY DR Bedford, MA 01730 |
Contact | James Mcmahon |
Correspondent | James Mcmahon Covidien LLC 15 CROSBY DR Bedford, MA 01730 |
Product Code | FTM |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-28 |
Decision Date | 2012-05-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884523000153 | K120605 | 000 |
10884523000054 | K120605 | 000 |
10884523000047 | K120605 | 000 |
10884523000245 | K120605 | 000 |
10884523000221 | K120605 | 000 |
10884523000207 | K120605 | 000 |
10884523000191 | K120605 | 000 |
10884523000184 | K120605 | 000 |
10884523000016 | K120605 | 000 |
10884523000061 | K120605 | 000 |
10884523000078 | K120605 | 000 |
10884523000085 | K120605 | 000 |
10884523000214 | K120605 | 000 |
10884523000177 | K120605 | 000 |
10884523000160 | K120605 | 000 |
10884523000139 | K120605 | 000 |
10884523000122 | K120605 | 000 |
10884523000115 | K120605 | 000 |
10884523000108 | K120605 | 000 |
10884523000092 | K120605 | 000 |
10884523000146 | K120605 | 000 |