The following data is part of a premarket notification filed by Dilling Co. with the FDA for Retractor, Gerbode Sternal.
Device ID | K760650 |
510k Number | K760650 |
Device Name: | RETRACTOR, GERBODE STERNAL |
Classification | Suture, Nonabsorbable, Silk |
Applicant | DILLING CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GAP |
CFR Regulation Number | 878.5030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-15 |
Decision Date | 1976-09-21 |