510(k) K872362

FRIGITRONICS ACC-1000 CAPSULE CUTTER by Frigitronics of Connecticut, Inc. — Product Code HQC

K872362 is an FDA 510(k) premarket notification submitted by Frigitronics of Connecticut, Inc. for the device "FRIGITRONICS ACC-1000 CAPSULE CUTTER". The FDA issued a decision of Substantially Equivalent on July 27, 1987. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Frigitronics of Connecticut, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1987
Date Received
June 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type