The following data is part of a premarket notification filed by Custom Surgical Products, Inc. with the FDA for Cspi Specimen Trap (non-sterile).
Device ID | K870874 |
510k Number | K870874 |
Device Name: | CSPI SPECIMEN TRAP (NON-STERILE) |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | CUSTOM SURGICAL PRODUCTS, INC. 421 WALLER Bossier City, LA 71112 |
Contact | Lowell L Price |
Correspondent | Lowell L Price CUSTOM SURGICAL PRODUCTS, INC. 421 WALLER Bossier City, LA 71112 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-03 |
Decision Date | 1988-04-19 |