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510(k) K850242

CRYSTAL MANUAL BREAST PUMP by Crystal Medical Products, Inc. — Product Code HGY

K850242 is an FDA 510(k) premarket notification submitted by Crystal Medical Products, Inc. for the device "CRYSTAL MANUAL BREAST PUMP". The FDA issued a decision of Substantially Equivalent on February 25, 1985. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150. Crystal Medical Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1985
Date Received
January 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Non-Powered
Device Class
Class I
Regulation Number
884.5150
Review Panel
OB
Submission Type

Other clearances by Crystal Medical Products, Inc.

  • K861513 — LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP (August 8, 1986)
  • K853107 — AXICARE CM-14 AUTOMATIC BREAST PUMP (November 19, 1985)
  • K850753 — NATURAL MOTHER BREAST PUMP (June 7, 1985)
  • K842766 — CRYSTAL MEDICAL MILK COLLECTION KIT (September 25, 1984)

Other clearances for product code HGY

  • K101538 — HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) (November 5, 2010)
  • K032845 — EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 (April 5, 2004)
  • K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (December 20, 2001)
  • K011519 — AMEDA HYGIENIKIT (August 15, 2001)
  • K971231 — WHITE RIVER MINI MANUAL BREAST PUMP (May 19, 1997)
  • K962828 — EVERT-IT (February 10, 1997)
  • K952034 — MEDELA'S FOOT PUMP (September 12, 1995)
  • K952035 — NIPLETTE (July 28, 1995)
  • K925738 — WHITE RIVER MANUAL BREAST PUMP (May 4, 1994)
  • K912355 — MOTHERS TOUCH ONE HAND BREAST PUMP (December 10, 1993)

FDA data resources