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510(k) K862367

PRO-CLEAN by Dermacare Products, Inc.

K862367 is an FDA 510(k) premarket notification submitted by Dermacare Products, Inc. for the device "PRO-CLEAN". The FDA issued a decision of Substantially Equivalent on July 8, 1986. Dermacare Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1986
Date Received
June 24, 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)
  • K863279 — SURGI-TEK TUBE POSITIONER (September 9, 1986)
  • K863280 — DERMAMARKER (September 9, 1986)
  • K863278 — SURGI-WIPES (September 2, 1986)
  • K853374 — CORRECT-A-COUNT (September 5, 1985)

FDA data resources