510(k) K896708

PERLINK CASSETTE, KIRAN CASSETTE by Perlink USA, Inc. — Product Code IXA

K896708 is an FDA 510(k) premarket notification submitted by Perlink USA, Inc. for the device "PERLINK CASSETTE, KIRAN CASSETTE". The FDA issued a decision of Substantially Equivalent on May 7, 1990. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. Perlink USA, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1990
Date Received
November 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type