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510(k) K853107

AXICARE CM-14 AUTOMATIC BREAST PUMP by Crystal Medical Products, Inc. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1985
Date Received
July 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances by Crystal Medical Products, Inc.

  • K861513 — LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP (August 8, 1986)
  • K850753 — NATURAL MOTHER BREAST PUMP (June 7, 1985)
  • K850242 — CRYSTAL MANUAL BREAST PUMP (February 25, 1985)
  • K842766 — CRYSTAL MEDICAL MILK COLLECTION KIT (September 25, 1984)

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