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510(k) K830294

MEDICAL EXAM TABLE by Coe Laboratories, Inc. — Product Code LGX

K830294 is an FDA 510(k) premarket notification submitted by Coe Laboratories, Inc. for the device "MEDICAL EXAM TABLE". The FDA issued a decision of Substantially Equivalent on January 11, 1984. The device falls under product code LGX (Table, Examination, Medical, Powered), a Class I device regulated under 21 CFR 878.4960. Coe Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1984
Date Received
January 27, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Examination, Medical, Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
HO
Submission Type

Other clearances by Coe Laboratories, Inc.

  • K903292 — ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS (October 19, 1990)
  • K894282 — FIRST IMPRESSION TM (December 22, 1989)
  • K894281 — FIRST IMPRESSION WITH CHLORHEXIDINE (September 26, 1989)
  • K891140 — OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT (May 1, 1989)
  • K885010 — TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING (February 13, 1989)
  • K881422 — COE PAK AUTO MIX, REGULAR OR HARD SET (October 31, 1988)
  • K881091 — OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL (June 28, 1988)
  • K863882 — OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE (November 18, 1986)
  • K842877 — ABSOLUTE VINYL POLYSILOXANE IMPRESS (March 11, 1985)
  • K844325 — COE-LITE POLYMERIZATION UNIT (December 11, 1984)

Other clearances for product code LGX

  • K945163 — ECHOCARDIOGRAPHY (February 17, 1995)
  • K894134 — POWER EXAMINATION TABLE MODEL # 411 (August 28, 1989)
  • K894144 — POWER EXAMINATION TABLE MODEL # 405 (August 28, 1989)
  • K883680 — MEDALIST EXAMINATION TABLE (October 4, 1988)
  • K882010 — POWER EXAMINATION TABLE (July 13, 1988)
  • K864072 — ADEC 1005-C CHAIR (November 7, 1986)
  • K860519 — RELIANCE MODEL 200 PODIATRY CHAIR (February 19, 1986)
  • K845023 — STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000 (January 28, 1985)
  • K832768 — S & W SW52E W/POWER BACK LIFT (September 20, 1983)
  • K820823 — MULTIPLE, MODEL #17 (April 21, 1982)

FDA data resources