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 |