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510(k) K854241

AOT EXTERNAL COMPRESS DEVICE by Advanced Ortho-Technology, Inc. — Product Code HWN

K854241 is an FDA 510(k) premarket notification submitted by Advanced Ortho-Technology, Inc. for the device "AOT EXTERNAL COMPRESS DEVICE". The FDA issued a decision of Substantially Equivalent on March 3, 1986. The device falls under product code HWN (Instrument, Compression), a Class I device regulated under 21 CFR 888.4540. Advanced Ortho-Technology, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1986
Date Received
October 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Compression
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Advanced Ortho-Technology, Inc.

  • K861937 — AQUACEL SURGICAL PREP PADS (June 6, 1986)
  • K854344 — AQUACEL SURGICAL PREP PADS (November 13, 1985)

Other clearances for product code HWN

  • K792253 — ARICULATED TENSION DEVICE SYNTHES TEN (December 5, 1979)
  • K770349 — RIGID TEACHING ATTACHMENT (March 7, 1977)
  • K760970 — FLORIO CPC BAND (November 23, 1976)

FDA data resources