The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Bowie-dick Test Card Catalog Number 008018.
| Device ID | K897045 |
| 510k Number | K897045 |
| Device Name: | BOWIE-DICK TEST CARD CATALOG NUMBER 008018 |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Contact | Glenn Mattei |
| Correspondent | Glenn Mattei EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-19 |
| Decision Date | 1990-02-15 |