510(k) K925496
K925496 is an FDA 510(k) premarket notification submitted by Pymah Corp. for the device "ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK". The FDA issued a decision of Substantially Equivalent on February 1, 1994. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Pymah Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1994
- Date Received
- October 30, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Biological Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type