The following data is part of a premarket notification filed by Westmark, Sterile Packing Systems, Inc. (sps) with the FDA for Surgical Connecting Tubes.
Device ID | K883473 |
510k Number | K883473 |
Device Name: | SURGICAL CONNECTING TUBES |
Classification | Tubing, Noninvasive |
Applicant | WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids, MI 49507 |
Contact | Tim Sagers |
Correspondent | Tim Sagers WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids, MI 49507 |
Product Code | GAZ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-16 |
Decision Date | 1988-08-25 |