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510(k) K800801

ANALGESIA UNITS, OXYGEN & NITRATE DEVICE by Spica, Inc. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1980
Date Received
April 10, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
Review Panel
AN
Submission Type

Other clearances by Spica, Inc.

  • K780364 — MANIFOLD KIT (March 30, 1978)
  • K780365 — OXYGEN/NITROUS OXIDE OUTLET (March 30, 1978)

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