The following data is part of a premarket notification filed by A.r. Medicom, Inc. with the FDA for Medicom Self-sealing Sterilization Pouch.
| Device ID | K070428 |
| 510k Number | K070428 |
| Device Name: | MEDICOM SELF-SEALING STERILIZATION POUCH |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | A.R. MEDICOM, INC. 1200 55TH AVE. Montreal, Quebec, CA H8t 3j8 |
| Contact | Jason Ludvig |
| Correspondent | Jason Ludvig A.R. MEDICOM, INC. 1200 55TH AVE. Montreal, Quebec, CA H8t 3j8 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-13 |
| Decision Date | 2007-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889950002183 | K070428 | 000 |
| D6620704375582 | K070428 | 000 |
| D6620704375822 | K070428 | 000 |
| 10889950002114 | K070428 | 000 |
| 10889950002121 | K070428 | 000 |
| 10889950002138 | K070428 | 000 |
| 10889950002145 | K070428 | 000 |
| 10889950002152 | K070428 | 000 |
| 10889950002169 | K070428 | 000 |
| 10889950002176 | K070428 | 000 |
| D6620704375412 | K070428 | 000 |