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510(k) K821084

UNIVERSAL TRIAL FRAMEE by Medical Equipment Designs, Inc. — Product Code HPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
April 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Frame, Trial, Ophthalmic
Device Class
Class I
Regulation Number
886.1415
Review Panel
OP
Submission Type

Other clearances by Medical Equipment Designs, Inc.

  • K911308 — CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE (September 11, 1991)
  • K894152 — MEDITHERM (June 11, 1990)
  • K895375 — MULTISPIRO (November 27, 1989)
  • K851277 — MICROSPIRO-SDS (April 19, 1985)
  • K840908 — CHESTAC-25F SPIROMETER (May 14, 1984)
  • K840929 — FRC 85 SERIES SPIROMETER (May 14, 1984)
  • K821083 — P.D. METER (June 14, 1982)
  • K821082 — TRIAL LENS SET (June 14, 1982)
  • K821107 — EXOPHTHALMOMETER (June 14, 1982)
  • K821081 — CHART PROJECTOR (June 14, 1982)

Other clearances for product code HPA

  • K852548 — ATL 225 MW TRAIL LENS SET (July 31, 1985)
  • K852126 — ATF 101 TRAIL FRAME (June 5, 1985)
  • K841768 — WOODLYN LIGHTWEIGHT TRIAL FRAME (June 1, 1984)
  • K833669 — IMAGE DEFLECTOR (March 27, 1984)