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510(k) K832768

S & W SW52E W/POWER BACK LIFT by S & W Enterprises, Inc. — Product Code LGX

K832768 is an FDA 510(k) premarket notification submitted by S & W Enterprises, Inc. for the device "S & W SW52E W/POWER BACK LIFT". The FDA issued a decision of Substantially Equivalent on September 20, 1983. The device falls under product code LGX (Table, Examination, Medical, Powered), a Class I device regulated under 21 CFR 878.4960. S & W Enterprises, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1983
Date Received
August 16, 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 S & W Enterprises, Inc.

  • K864817 — S&W MODEL HIGH-LOW MAT TABLE, VARIOUS MODELS (January 5, 1987)
  • K841145 — TILT TABLE 53 (April 13, 1984)
  • K830873 — S & W MODEL ASO (May 13, 1983)
  • K830874 — S & W MODEL SW 37 (April 8, 1983)
  • K830875 — S & W MODEL 29 (April 8, 1983)

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)
  • K830294 — MEDICAL EXAM TABLE (January 11, 1984)
  • K820823 — MULTIPLE, MODEL #17 (April 21, 1982)

FDA data resources