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510(k) K861937

AQUACEL SURGICAL PREP PADS by Advanced Ortho-Technology, Inc.

K861937 is an FDA 510(k) premarket notification submitted by Advanced Ortho-Technology, Inc. for the device "AQUACEL SURGICAL PREP PADS". The FDA issued a decision of Substantially Equivalent on June 6, 1986. Advanced Ortho-Technology, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1986
Date Received
May 20, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Advanced Ortho-Technology, Inc.

  • K854241 — AOT EXTERNAL COMPRESS DEVICE (March 3, 1986)
  • K854344 — AQUACEL SURGICAL PREP PADS (November 13, 1985)

FDA data resources