The following data is part of a premarket notification filed by Alba-waldensian, Inc. with the FDA for Sterile Impervious Orthopedic Stockin.
Device ID | K792357 |
510k Number | K792357 |
Device Name: | STERILE IMPERVIOUS ORTHOPEDIC STOCKIN |
Classification | Drape, Surgical |
Applicant | ALBA-WALDENSIAN, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-21 |
Decision Date | 1979-12-18 |