The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Economy Plastic Sock-bk2084-aid.
Device ID | K831539 |
510k Number | K831539 |
Device Name: | ECONOMY PLASTIC SOCK-BK2084-AID |
Classification | Adaptor, Dressing |
Applicant | FRED SAMMONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILD |
CFR Regulation Number | 890.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-12 |
Decision Date | 1983-06-08 |