The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Microclip, Williams.
Device ID | K780586 |
510k Number | K780586 |
Device Name: | MICROCLIP, WILLIAMS |
Classification | Staple, Implantable |
Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-04-12 |
Decision Date | 1978-05-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00821925037717 | K780586 | 000 |