510(k) K913643

MUCOUS SPECIMEN TRAP by Medical Device Inspection Co., Inc. — Product Code BYZ

K913643 is an FDA 510(k) premarket notification submitted by Medical Device Inspection Co., Inc. for the device "MUCOUS SPECIMEN TRAP". The FDA issued a decision of Substantially Equivalent on October 10, 1991. The device falls under product code BYZ (Trap, Sterile Specimen), a Class II device regulated under 21 CFR 880.6740. Medical Device Inspection Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1991
Date Received
August 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trap, Sterile Specimen
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type