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510(k) K811403

AXICARE BREAST PUMP MODEL by Neonatal Corp. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1981
Date Received
May 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances by Neonatal Corp.

  • K811364 — AXICARE BREAST SHELL (August 3, 1981)
  • K811707 — AXICUT DISPOSABLE SCALPEL (July 20, 1981)

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