FDA.reportPublic FDA data

510(k) DEN040004

Device
CELLERATION MIST THERAPY SYSTEM
Applicant
Celleration
510(k) number
DEN040004
Product code
NRB
Decision
Unknown (DENG)
Decision date
2004-06-25
Date received
2004-04-29
Regulation
878.4410
Classification name
Wound Cleaner, Ultrasound
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Post-NSE
Third party reviewed
N

Applicant Contact#

Contact
DAVID L BREMSETH
Address
6570 Edenvale Blvd. Eden Prairie MN US 55346 55346

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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