The following data is part of a premarket notification filed by Canadian Technical Tape, Ltd. with the FDA for Process Indicator Tape For Steam Sterilization.
| Device ID | K140940 |
| 510k Number | K140940 |
| Device Name: | PROCESS INDICATOR TAPE FOR STEAM STERILIZATION |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | CANADIAN TECHNICAL TAPE, LTD. 125 HIGHPOWER ROAD Rochester, NY 14623 |
| Contact | Gary Socola |
| Correspondent | Gary Socola CANADIAN TECHNICAL TAPE, LTD. 125 HIGHPOWER ROAD Rochester, NY 14623 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-14 |
| Decision Date | 2014-10-27 |
| Summary: | summary |