510(k) K884696

RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET by Laboratoire Ccd C/O Washington Regulatory Services — Product Code HDR

K884696 is an FDA 510(k) premarket notification submitted by Laboratoire Ccd C/O Washington Regulatory Services for the device "RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET". The FDA issued a decision of Substantially Equivalent on January 27, 1989. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250. Laboratoire Ccd C/O Washington Regulatory Services has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1989
Date Received
November 9, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Cervical
Device Class
Class II
Regulation Number
884.5250
Review Panel
OB
Submission Type