The following data is part of a premarket notification filed by North American Science Assoc., Inc. with the FDA for Namsa Biological Indicator Spore Strips (dual Species) Namsa Biological Indicator Spore Strips (single Species).
Device ID | K141244 |
510k Number | K141244 |
Device Name: | NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES) |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-14 |
Decision Date | 2014-09-09 |
Summary: | summary |