510(k) K911076

JAIN QUICK COUNT by Jain Surgical Equipment, Inc. — Product Code MMK

K911076 is an FDA 510(k) premarket notification submitted by Jain Surgical Equipment, Inc. for the device "JAIN QUICK COUNT". The FDA issued a decision of Substantially Equivalent on May 30, 1991. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Jain Surgical Equipment, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1991
Date Received
March 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Sharps
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type