The following data is part of a premarket notification filed by Nev's Ink, Inc with the FDA for Nev's Ink Autoclave Tapes.
| Device ID | K101580 |
| 510k Number | K101580 |
| Device Name: | NEV'S INK AUTOCLAVE TAPES |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | NEV'S INK, INC 2500 W. SUNSET DR Waukesha, WI 53189 -6326 |
| Contact | Dave Marose |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-07 |
| Decision Date | 2010-07-01 |