The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Surgeon's Gloves.
Device ID | K842884 |
510k Number | K842884 |
Device Name: | SURGEON'S GLOVES |
Classification | Surgeon's Gloves |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield , IL 60015 - |
Contact | John Brda |
Correspondent | John Brda TRAVENOL LABORATORIES, S.A. Deerfield , IL 60015 - |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-23 |
Decision Date | 1984-11-29 |