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510(k) K864176

GENTLE FEEL by Mali, Inc. — Product Code HFS

K864176 is an FDA 510(k) premarket notification submitted by Mali, Inc. for the device "GENTLE FEEL". The FDA issued a decision of Substantially Equivalent on November 4, 1986. The device falls under product code HFS (Shield, Nipple), a Class I device regulated under 21 CFR 880.5630. Mali, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1986
Date Received
October 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Nipple
Device Class
Class I
Regulation Number
880.5630
Review Panel
HO
Submission Type

Other clearances by Mali, Inc.

  • K855209 — NIR LAT MALE EXTERNAL CATHETER (January 10, 1986)

Other clearances for product code HFS

  • K944117 — AVENT NIPPLE SHIELD (October 5, 1994)
  • K944177 — BREAST SHELL (October 5, 1994)
  • K935340 — COMFORT PLUS NIPPLE SHIELDS (January 21, 1994)
  • K935341 — COMFORT PLUS BREAST SHELLS (January 21, 1994)
  • K930238 — BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS (August 16, 1993)
  • K923577 — BREAST SHELLS (January 22, 1993)
  • K861608 — UNICARE BREAST SHELLS (July 15, 1986)
  • K853176 — CANNON BABYSAFE NIPPLE SHIELDS (August 22, 1985)
  • K840877 — ARGYLE ENTERNAL FEEDING BAG W/ADMIN (June 28, 1984)
  • K833450 — NUK BREAST SHIELD (November 21, 1983)

FDA data resources