The following data is part of a premarket notification filed by Steritec Products Mfg. Co., Inc. with the FDA for Steri-pak Bowie Dick Test Pack.
| Device ID | K982188 |
| 510k Number | K982188 |
| Device Name: | STERI-PAK BOWIE DICK TEST PACK |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERITEC PRODUCTS MFG. CO., INC. 680 ATCHISON WAY SUITE 600 Castle Rock, CO 80104 |
| Contact | Lon Bruso |
| Correspondent | Lon Bruso STERITEC PRODUCTS MFG. CO., INC. 680 ATCHISON WAY SUITE 600 Castle Rock, CO 80104 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-22 |
| Decision Date | 1998-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10326053105743 | K982188 | 000 |
| 10326053105934 | K982188 | 000 |
| 10326053105880 | K982188 | 000 |