The following data is part of a premarket notification filed by Intera Corp. with the FDA for Surgical Drape & Drape Accessories.
Device ID | K863732 |
510k Number | K863732 |
Device Name: | SURGICAL DRAPE & DRAPE ACCESSORIES |
Classification | Drape, Surgical |
Applicant | INTERA CORP. P.O. BOX 25376 Chattanooga, TN 37422 -5376 |
Contact | Bruce Lindquist |
Correspondent | Bruce Lindquist INTERA CORP. P.O. BOX 25376 Chattanooga, TN 37422 -5376 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-23 |
Decision Date | 1986-10-23 |