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510(k) K863279

SURGI-TEK TUBE POSITIONER by Dermacare Products, Inc.

K863279 is an FDA 510(k) premarket notification submitted by Dermacare Products, Inc. for the device "SURGI-TEK TUBE POSITIONER". The FDA issued a decision of Substantially Equivalent on September 9, 1986. Dermacare Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1986
Date Received
August 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Dermacare Products, Inc.

  • K882494 — ELAN-E DISPOSALBE DRAPE (July 8, 1988)
  • K882421 — INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE (June 30, 1988)
  • K871910 — SURGITEK DISPOSABLE BIPOLAR CORD (June 1, 1987)
  • K863280 — DERMAMARKER (September 9, 1986)
  • K863278 — SURGI-WIPES (September 2, 1986)
  • K862367 — PRO-CLEAN (July 8, 1986)
  • K853374 — CORRECT-A-COUNT (September 5, 1985)

FDA data resources