510(k) K852901

DOUBLE PUNCTURE INSTRUMENTS by L.A.S.E.R., Inc. — Product Code HET

K852901 is an FDA 510(k) premarket notification submitted by L.A.S.E.R., Inc. for the device "DOUBLE PUNCTURE INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on Oct 16, 1985. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. L.A.S.E.R., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 16, 1985
Date Received
Jul 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type