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510(k) K801840

SURGICAL BANDAGES/SUNLEEP DX by Martin'S Maine Exchange — Product Code NAD

K801840 is an FDA 510(k) premarket notification submitted by Martin'S Maine Exchange for the device "SURGICAL BANDAGES/SUNLEEP DX". The FDA issued a decision of Substantially Equivalent on September 9, 1980. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Martin'S Maine Exchange has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1980
Date Received
August 1, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

Other clearances by Martin'S Maine Exchange

  • K810008 — ALP-KII (January 16, 1981)
  • K801837 — PLASTIC STRIP BANDAGES (October 31, 1980)
  • K801839 — DISPOSABLE HYPODERMIC NEEDLES (September 16, 1980)

Other clearances for product code NAD

  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)

FDA data resources