510(k) K821414

MODEL 80 BC by Western Laboratories Corp.

K821414 is an FDA 510(k) premarket notification submitted by Western Laboratories Corp. for the device "MODEL 80 BC". The FDA issued a decision of Substantially Equivalent on May 27, 1982. Western Laboratories Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1982
Date Received
May 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No