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Dc-Defibrillator, High Energy, (Including Paddles)

FDA product code DRK · 1 cleared devices

Class 3 Cardiovascular
Regulation
21 CFR 870.5300
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1993-10-07 – 1993-10-07

PMA to be filed by 12/26/96 (FR 50706 (9/27/96))

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