The following data is part of a premarket notification filed by Gotfried Medical, Inc. with the FDA for Made-to-measure Surgical Elastic Support.
Device ID | K823737 |
510k Number | K823737 |
Device Name: | MADE-TO-MEASURE SURGICAL ELASTIC SUPPORT |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | GOTFRIED MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-13 |
Decision Date | 1983-01-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
G420021 | K823737 | 000 |
G420331 | K823737 | 000 |
G420332 | K823737 | 000 |
G420333 | K823737 | 000 |
G420334 | K823737 | 000 |
G420335 | K823737 | 000 |
G420336 | K823737 | 000 |
G420337 | K823737 | 000 |
G420338 | K823737 | 000 |
G420339 | K823737 | 000 |
G420341 | K823737 | 000 |
G420342 | K823737 | 000 |
G420400 | K823737 | 000 |
G420401 | K823737 | 000 |
G420402 | K823737 | 000 |
G420403 | K823737 | 000 |
G420309 | K823737 | 000 |
G420308 | K823737 | 000 |
G420307 | K823737 | 000 |
G420022 | K823737 | 000 |
G420101 | K823737 | 000 |
G420102 | K823737 | 000 |
G420103 | K823737 | 000 |
G420104 | K823737 | 000 |
G420106 | K823737 | 000 |
G420201 | K823737 | 000 |
G420202 | K823737 | 000 |
G420300 | K823737 | 000 |
G420301 | K823737 | 000 |
G420302 | K823737 | 000 |
G420303 | K823737 | 000 |
G420304 | K823737 | 000 |
G420305 | K823737 | 000 |
G420306 | K823737 | 000 |
G420404 | K823737 | 000 |
G420405 | K823737 | 000 |
G420430 | K823737 | 000 |
G420431 | K823737 | 000 |
G420432 | K823737 | 000 |
G420441 | K823737 | 000 |
G420442 | K823737 | 000 |
G420451 | K823737 | 000 |
G420452 | K823737 | 000 |
G420453 | K823737 | 000 |
G420460 | K823737 | 000 |
G420461 | K823737 | 000 |
G420470 | K823737 | 000 |
G420471 | K823737 | 000 |
G420472 | K823737 | 000 |
G420473 | K823737 | 000 |
G420474 | K823737 | 000 |
G420426 | K823737 | 000 |
G420425 | K823737 | 000 |
G420424 | K823737 | 000 |
G420406 | K823737 | 000 |
G420407 | K823737 | 000 |
G420408 | K823737 | 000 |
G420409 | K823737 | 000 |
G420410 | K823737 | 000 |
G420412 | K823737 | 000 |
G420413 | K823737 | 000 |
G420414 | K823737 | 000 |
G420415 | K823737 | 000 |
G420416 | K823737 | 000 |
G420417 | K823737 | 000 |
G420418 | K823737 | 000 |
G420420 | K823737 | 000 |
G420421 | K823737 | 000 |
G420422 | K823737 | 000 |
G420475 | K823737 | 000 |