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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 Nov 4, 1986. The device falls under product code HFS (Shield, Nipple), a Class I device regulated under 21 CFR 880.5630. Mali, Inc. has 1 other 510(k) clearance on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 4, 1986
Date Received
Oct 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
510(k) Exempt

Other clearances by Mali, Inc.

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

Other clearances for product code HFS

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

FDA data resources

Source: FDA 510(k) database entry for K864176. Report a data issue: hello@regdatalab.com.