The following data is part of a premarket notification filed by Healthcare Service And Supply with the FDA for Healthcare Service And Supply Alp Alternating Leg Pressure Pump And Gaarments For The Limb.
Device ID | K974318 |
510k Number | K974318 |
Device Name: | HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMB |
Classification | Sleeve, Limb, Compressible |
Applicant | HEALTHCARE SERVICE AND SUPPLY P.O. BOX 1788 Tustin, CA 92681 |
Contact | Rick Roeder |
Correspondent | Rick Roeder HEALTHCARE SERVICE AND SUPPLY P.O. BOX 1788 Tustin, CA 92681 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-17 |
Decision Date | 1998-02-13 |
Summary: | summary |