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510(k) K912355

MOTHERS TOUCH ONE HAND BREAST PUMP by Hollister, Inc. — Product Code HGY

K912355 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "MOTHERS TOUCH ONE HAND BREAST PUMP". The FDA issued a decision of Substantially Equivalent on December 10, 1993. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150. Hollister, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1993
Date Received
May 28, 1991
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 Hollister, Inc.

  • K123804 — INSTAFLO BOWEL CATHETER SYSTEM KIT (April 17, 2013)
  • K100273 — INSTAFLO BOWEL CATHETER SYSTEM KIT (April 22, 2010)
  • K090960 — VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 7208 (August 20, 2009)
  • K083153 — ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 (February 4, 2009)
  • K050483 — EVADRI BLADDER CONTROL SYSTEMS (April 12, 2005)
  • K040779 — RESTORE WOUND CLEANSER (May 17, 2004)
  • K013612 — INCARE PELVIC FLOOR THERAPY SYSTEM (March 19, 2002)
  • K013653 — INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE (March 5, 2002)
  • K013483 — INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT (January 14, 2002)
  • K013345 — INCARE INTERMITTENT CATHETER (January 7, 2002)

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)
  • K902552 — GERBER PRECIOUS CARE ELECTRIC BREAST PUMP (September 26, 1990)

FDA data resources