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9th Wave, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K963620
9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS
January 7, 1997
K963677
9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD
November 26, 1996
K963626
9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS
November 26, 1996