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510(k) K935341

COMFORT PLUS BREAST SHELLS by Marshall Baby Products — Product Code HFS

K935341 is an FDA 510(k) premarket notification submitted by Marshall Baby Products for the device "COMFORT PLUS BREAST SHELLS". The FDA issued a decision of Substantially Equivalent on January 21, 1994. The device falls under product code HFS (Shield, Nipple), a Class I device regulated under 21 CFR 880.5630. Marshall Baby Products has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1994
Date Received
November 5, 1993
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 Marshall Baby Products

  • K935340 — COMFORT PLUS NIPPLE SHIELDS (January 21, 1994)

Other clearances for product code HFS

  • K944177 — BREAST SHELL (October 5, 1994)
  • K944117 — AVENT NIPPLE SHIELD (October 5, 1994)
  • K935340 — COMFORT PLUS NIPPLE SHIELDS (January 21, 1994)
  • K930238 — BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS (August 16, 1993)
  • K923577 — BREAST SHELLS (January 22, 1993)
  • K864176 — GENTLE FEEL (November 4, 1986)
  • 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