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510(k) K873604

E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY by Electronic Waveform Laboratory, Inc. — Product Code LWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1988
Date Received
September 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Electrical Dental Anesthesia
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Electronic Waveform Laboratory, Inc.

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  • K081998 — H-WAVE SPORT (July 9, 2009)
  • K915230 — H WAVE MUSCLE STIMULATOR (May 8, 1992)
  • K862121 — E.W.L. P-TENS/H-WAVE (June 17, 1987)
  • K813601 — E.W.L. P-TENS MODEL(TENS (March 19, 1982)

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  • K935082 — 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION (January 26, 1994)
  • K935085 — 3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS (January 26, 1994)
  • K915717 — CEDETA (November 23, 1992)
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  • K910625 — ULTRACALM (May 15, 1992)