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510(k) K962828

EVERT-IT by Genesis Industries, Inc. — Product Code HGY

K962828 is an FDA 510(k) premarket notification submitted by Genesis Industries, Inc. for the device "EVERT-IT". The FDA issued a decision of Substantially Equivalent on February 10, 1997. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150. Genesis Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1997
Date Received
July 19, 1996
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 Genesis Industries, Inc.

  • K994361 — ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO (February 18, 2000)
  • K880377 — NOVO VIVO MODEL #17140 AND #17135 (April 4, 1988)
  • K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (February 16, 1988)
  • K833287 — SATIN CAST ECONOCAST (January 3, 1984)
  • K833290 — C & B 40 PENTRO C & B40 (January 3, 1984)
  • K833278 — C & B 45 (December 29, 1983)
  • K833289 — C & B 61 PENTRON C & B61 (December 29, 1983)
  • K833280 — SUPRA AP CHOICE 83 (December 26, 1983)
  • K833285 — RX IV PENTRON IV (December 22, 1983)
  • K833288 — C & B57 PENTRON C & B57 (December 20, 1983)

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

FDA data resources