The following data is part of a premarket notification filed by North American Science Assoc., Inc. with the FDA for Namsa Steam Self-contained Biological Indicators.
| Device ID | K113302 |
| 510k Number | K113302 |
| Device Name: | NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | NORTH AMERICAN SCIENCE ASSOC., INC. 6750 WALES RD. Northwood, OH 43619 |
| Contact | Julie Wheeler |
| Correspondent | Julie Wheeler NORTH AMERICAN SCIENCE ASSOC., INC. 6750 WALES RD. Northwood, OH 43619 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-08 |
| Decision Date | 2012-01-20 |
| Summary: | summary |