The following data is part of a premarket notification filed by North American Science Assoc., Inc. with the FDA for Sportrol Rapid Sterility Indicator.
| Device ID | K962649 |
| 510k Number | K962649 |
| Device Name: | SPORTROL RAPID STERILITY INDICATOR |
| Classification | Indicator, Chemical, Enzymatic, Sterilization Process |
| Applicant | NORTH AMERICAN SCIENCE ASSOC., INC. 2261 TRACY RD. Northwood, OH 43619 |
| Contact | Matthew Sliva |
| Correspondent | Matthew Sliva NORTH AMERICAN SCIENCE ASSOC., INC. 2261 TRACY RD. Northwood, OH 43619 |
| Product Code | MTC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-08 |
| Decision Date | 1997-09-26 |