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510(k) K881359

DECALCIFYING SOLUTION II by Stephens Scientific — Product Code KOX

K881359 is an FDA 510(k) premarket notification submitted by Stephens Scientific for the device "DECALCIFYING SOLUTION II". The FDA issued a decision of Substantially Equivalent on April 19, 1988. The device falls under product code KOX (Solvent, Adhesive Tape), a Class I device regulated under 21 CFR 878.4730. Stephens Scientific has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1988
Date Received
March 31, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solvent, Adhesive Tape
Device Class
Class I
Regulation Number
878.4730
Review Panel
SU
Submission Type

Other clearances by Stephens Scientific

  • K893772 — TISSUE EMBEDDING MEDIUM (June 22, 1989)
  • K872625 — DECALCIFYING SOLUTION (August 6, 1987)
  • K832011 — AMERI CLEAR (August 12, 1983)

Other clearances for product code KOX

  • K934790 — SEPP ADHESIVE REMOVER (March 11, 1994)
  • K931933 — CHAD LABS ADHESIVE BANDAGE REMOVER (July 8, 1993)
  • K924976 — ALLKARE(TM) ADHESIVE REMOVER WIPE (April 20, 1993)
  • K924571 — MEDI-SOL (April 6, 1993)
  • K925618 — 3M REMOVER LOTION PRODUCT NUMBER 86XX (March 31, 1993)
  • K923351 — SKIN SUPPORT PREP PAD (September 14, 1992)
  • K915150 — REMOVE ADHESIVE REMOVER (January 9, 1992)
  • K902009 — ELANTEC'S SURGICAL TAPE REMOVER (August 29, 1990)
  • K895293 — KEMI LABS - ADHESIVE BANDAGE REMOVER (February 9, 1990)
  • K893603 — REMOVE ADHESIVE REMOVER (July 14, 1989)

FDA data resources