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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 Jan 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 1 other 510(k) clearance on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 21, 1994
Date Received
Nov 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
510(k) Exempt

Other clearances by Marshall Baby Products

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

Other clearances for product code HFS

  • K944177 — BREAST SHELL (Oct 5, 1994)
  • K944117 — AVENT NIPPLE SHIELD (Oct 5, 1994)
  • K935340 — COMFORT PLUS NIPPLE SHIELDS (Jan 21, 1994)
  • K930238 — BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS (Aug 16, 1993)
  • K923577 — BREAST SHELLS (Jan 22, 1993)
  • K864176 — GENTLE FEEL (Nov 4, 1986)
  • 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 K935341. Report a data issue: hello@regdatalab.com.