510(k) K041562

CRYOTIP by Irvine Scientific Sales Co., Inc. — Product Code MQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2004
Date Received
June 10, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtools, Assisted Reproduction (Pipettes)
Device Class
Class II
Regulation Number
884.6130
Review Panel
OB
Submission Type