The following data is part of a premarket notification filed by Dynamedics, Inc. with the FDA for Dylnamedics A.s.a.p..
Device ID | K924973 |
510k Number | K924973 |
Device Name: | DYLNAMEDICS A.S.A.P. |
Classification | Bed, Air Fluidized |
Applicant | DYNAMEDICS, INC. 30 ADELAIDE ST. NORTH LONDON, ONTARIO, Canada, N6b3n5, CA |
Contact | Stephen Matheson |
Correspondent | Stephen Matheson DYNAMEDICS, INC. 30 ADELAIDE ST. NORTH LONDON, ONTARIO, Canada, N6b3n5, CA |
Product Code | INX |
CFR Regulation Number | 890.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-30 |
Decision Date | 1993-10-15 |