510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K960847Substantially Equivalent

Dermaseal

Bellingham Medical, Inc., Mendota Heights MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960847 is the FDA 510(k) clearance record for DERMASEAL, cleared for Bellingham Medical, Inc. on under FDA product code MGP (Dressing, Wound And Burn, Occlusive). FDA records list one 510(k) clearance for Bellingham Medical, Inc. As of , FDA records show no recalls naming K960847.

Clearance record

Decision date
Received
(43 days to decision)
Product code
MGP Dressing, Wound And Burn, Occlusive
Device class
Unclassified
Review panel
Unknown
Applicant
Bellingham Medical, Inc. 2401 Pilot Knob Rd., Suite 118, Mendota Heights MN
510(k) summary
Statement
Third party review
No

Clearances, product code MGP

Trailing 12 months

FDA records hold no clearances under product code MGP in the trailing twelve months.

FDA records show no clearances under product code MGP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MGP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260