Home / 510(k) Clearances / K991388

510(k) K991388

ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M by Pacific Andrology, Inc. — Product Code MQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1999
Date Received
April 21, 1999
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

Other clearances by Pacific Andrology, Inc.

  • K991381 — PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERE (September 24, 1999)

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