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510(k) K973268

MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM by Microaire Surgical Instruments, Inc. — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1997
Date Received
August 29, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

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  • K212024 — PAL System (June 10, 2022)
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  • K192694 — PAL Single-Use Cannulas (May 14, 2020)
  • K181819 — SMARTRELEASE Endoscopic Soft Tissue Release System (November 6, 2018)
  • K171286 — PAL Multi-Use Cannulas and PAL Manual Wand (October 13, 2017)

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  • K242028 — Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) (November 19, 2024)
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  • K233901 — Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009 (March 20, 2024)