510(k) K894006
K894006 is an FDA 510(k) premarket notification submitted by Saniserv, Inc. for the device "SANISERV SURGICAL SLUSH SYSTEM". The FDA issued a decision of Substantially Equivalent on November 3, 1989. 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
- November 3, 1989
- Date Received
- June 5, 1989
- 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