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510(k) K861513

LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP by Crystal Medical Products, Inc. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1986
Date Received
April 23, 1986
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.

  • K853107 — AXICARE CM-14 AUTOMATIC BREAST PUMP (November 19, 1985)
  • 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)

Other clearances for product code HGX

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  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)
  • K252420 — Wearable Breast Pump (Model W12) (February 13, 2026)
  • K251423 — Spectra S1 Pro; Spectra S2 Pro (February 6, 2026)
  • K253498 — Pump In Style® Pro+ (January 22, 2026)
  • K253072 — Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 P (December 23, 2025)
  • K252342 — Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) (December 19, 2025)
  • K252754 — Wearable Electric Breast Pump (YM-8803) (December 19, 2025)