510(k) K970799
K970799 is an FDA 510(k) premarket notification submitted by Alexander Mfg. Co. for the device "ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)". The FDA issued a decision of Substantially Equivalent on May 14, 1997. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Alexander Mfg. Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 1997
- Date Received
- March 4, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialyzer Reprocessing System
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type