The following data is part of a premarket notification filed by A-t Surgical Mfg. Co., Inc. with the FDA for Compression Legging Device.
Device ID | K871889 |
510k Number | K871889 |
Device Name: | COMPRESSION LEGGING DEVICE |
Classification | Legging, Compression, Non-inflatable |
Applicant | A-T SURGICAL MFG. CO., INC. 359 DWIGHT ST. Holyoke, MA 01040 |
Contact | Eugene Kirejczyk |
Correspondent | Eugene Kirejczyk A-T SURGICAL MFG. CO., INC. 359 DWIGHT ST. Holyoke, MA 01040 |
Product Code | LLK |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-15 |
Decision Date | 1987-08-04 |