510(k) K971971
K971971 is an FDA 510(k) premarket notification submitted by Board Of Directors, Albert Browne , Ltd. for the device "BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK". The FDA issued a decision of Substantially Equivalent on Jul 10, 1998. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Board Of Directors, Albert Browne , Ltd. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 10, 1998
- Date Received
- May 29, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Indicator, Physical/Chemical Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type
- 510(k)