510(k) K896802
K896802 is an FDA 510(k) premarket notification submitted by Westmark, Sterile Packing Systems, Inc. (Sps) for the device "MAGNET PAD". The FDA issued a decision of Substantially Equivalent on December 27, 1989. The device falls under product code LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use), a Class I device regulated under 21 CFR 862.2050. Westmark, Sterile Packing Systems, Inc. (Sps) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 1989
- Date Received
- December 1, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type