510(k) K913777
K913777 is an FDA 510(k) premarket notification submitted by Taylor Corp. for the device "SELF-CONTAINED SURGICAL SLUSH FREEZER". The FDA issued a decision of Substantially Equivalent on September 25, 1991. The device falls under product code JRM (Freezer), a Class I device regulated under 21 CFR 862.2050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 1991
- Date Received
- August 14, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Freezer
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type