The following data is part of a premarket notification filed by Arjo Wiggins Medical, Inc. with the FDA for Arjorad Sterile Wrap.
Device ID | K110954 |
510k Number | K110954 |
Device Name: | ARJORAD STERILE WRAP |
Classification | Wrap, Sterilization |
Applicant | ARJO WIGGINS MEDICAL, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Contact | Jon Ward |
Correspondent | Jon Ward ARJO WIGGINS MEDICAL, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-05 |
Decision Date | 2012-08-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00815588021145 | K110954 | 000 |
00815588020841 | K110954 | 000 |
00815588020865 | K110954 | 000 |
00815588020889 | K110954 | 000 |
00815588020902 | K110954 | 000 |
00815588020926 | K110954 | 000 |
00815588020933 | K110954 | 000 |
00815588020957 | K110954 | 000 |
00815588020971 | K110954 | 000 |
00815588020995 | K110954 | 000 |
00815588021015 | K110954 | 000 |
00815588021084 | K110954 | 000 |
00815588021107 | K110954 | 000 |
00815588021121 | K110954 | 000 |
00815588020827 | K110954 | 000 |