The following data is part of a premarket notification filed by Custom Surgical Products, Inc. with the FDA for Suction Cannulas.
Device ID | K841249 |
510k Number | K841249 |
Device Name: | SUCTION CANNULAS |
Classification | Cannula, Surgical, General & Plastic Surgery |
Applicant | CUSTOM SURGICAL PRODUCTS, INC. 421 WALLER Bossier City, LA 71112 |
Contact | Price R.n. |
Correspondent | Price R.n. CUSTOM SURGICAL PRODUCTS, INC. 421 WALLER Bossier City, LA 71112 |
Product Code | GEA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-21 |
Decision Date | 1984-06-04 |