The following data is part of a premarket notification filed by Westmark, Sterile Packing Systems, Inc. (sps) with the FDA for Magnet Pad.
Device ID | K896802 |
510k Number | K896802 |
Device Name: | MAGNET PAD |
Classification | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
Applicant | WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids, MI 49507 |
Contact | Sury Shoney |
Correspondent | Sury Shoney WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids, MI 49507 |
Product Code | LXG |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-01 |
Decision Date | 1989-12-27 |