The following data is part of a premarket notification filed by Canadian Technical Tape, Ltd. with the FDA for Canadian Technical Tape, Ltd. Lf Process Indicator Steam Sterilization Tape.
| Device ID | K161024 |
| 510k Number | K161024 |
| Device Name: | Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | Canadian Technical Tape, Ltd. 455 Cote-Vertu Blvd Montreal, CA H4n 1e8 |
| Contact | Howard Cohen |
| Correspondent | Gary Socola Highpower Validation And Testing Lab Services Inc. 125 Highpower Rd Rochester, NY 14623 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-12 |
| Decision Date | 2016-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50732224004162 | K161024 | 000 |
| 50732224004155 | K161024 | 000 |
| H834STDSTEAM1 | K161024 | 000 |