The following data is part of a premarket notification filed by Intertape Polymer Inc. with the FDA for Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape.
| Device ID | K191741 |
| 510k Number | K191741 |
| Device Name: | Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | Intertape Polymer Inc. 100 Paramount Dr Suite 300 Sarasota, FL 34232 |
| Contact | Michael Bryant |
| Correspondent | Gary J. Socola Highpower Validation Testing & Lab Service's Inc. 125 Highpower Road 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 | 2019-07-01 |
| Decision Date | 2019-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040115470 | K191741 | 000 |
| 50732224004124 | K191741 | 000 |
| 50732224004131 | K191741 | 000 |
| 50732224004148 | K191741 | 000 |
| 50732224004155 | K191741 | 000 |
| 50732224004162 | K191741 | 000 |
| 00889813027790 | K191741 | 000 |
| 00889813027806 | K191741 | 000 |
| 00889813027813 | K191741 | 000 |
| 10304040115456 | K191741 | 000 |
| 10304040115463 | K191741 | 000 |
| H834STDSTEAM1 | K191741 | 000 |