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510(k) K861188

SPERM CAPACITATION MEDIUM by Irvine Scientific — Product Code HDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1987
Date Received
March 31, 1986
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

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  • K894432 — MODIFIED HAM'S F-10 W/ALBUMIN (September 22, 1989)
  • K894405 — HTF WITH ALBUMIN (CATALOG NO. 9994) (September 22, 1989)
  • K874668 — SPERM WASHING MEDIUM #9983 & MODIFIED #9984 (March 31, 1988)
  • K872088 — FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) (August 14, 1987)
  • K872203 — CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) (August 14, 1987)
  • K872102 — SPERM WASHING MEDIUM #9932 (July 16, 1987)
  • K871577 — HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES (July 15, 1987)

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