The following data is part of a premarket notification filed by Lone Star Medical Products, Inc. with the FDA for Scotts Surgical Retractor And Elastic.
Device ID | K791665 |
510k Number | K791665 |
Device Name: | SCOTTS SURGICAL RETRACTOR AND ELASTIC |
Classification | Retractor |
Applicant | LONE STAR MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GAD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-21 |
Decision Date | 1979-09-19 |