The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Once-a-day Vertos Test Pack.
| Device ID | K082620 |
| 510k Number | K082620 |
| Device Name: | ONCE-A-DAY VERTOS TEST PACK |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. Long Island City, NY 11101 |
| Contact | Marian M Schuman |
| Correspondent | Marian M Schuman 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-09 |
| Decision Date | 2009-07-08 |
| Summary: | summary |