The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Once-a-day Bowie And Dick Test Pack..
| Device ID | K961156 |
| 510k Number | K961156 |
| Device Name: | ONCE-A-DAY BOWIE AND DICK TEST PACK. |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. Long Island City, NY 11101 |
| Contact | Thomas A Augurt, Ph.d. |
| Correspondent | Thomas A Augurt, Ph.d. PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. Long Island City, NY 11101 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-22 |
| Decision Date | 1997-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 70818087011777 | K961156 | 000 |