The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Protekt Gloves.
Device ID | K910920 |
510k Number | K910920 |
Device Name: | PROTEKT GLOVES |
Classification | Dress, Surgical |
Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Contact | Thomas L Craig |
Correspondent | Thomas L Craig INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Product Code | FYE |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-05 |
Decision Date | 1991-05-15 |