The following data is part of a premarket notification filed by Save-t-breath Distributors C.c. with the FDA for Stb Yankauer Sucker/nozzle.
Device ID | K933762 |
510k Number | K933762 |
Device Name: | STB YANKAUER SUCKER/NOZZLE |
Classification | Catheter And Tip, Suction |
Applicant | SAVE-T-BREATH DISTRIBUTORS C.C. P.O.BOX 87523 HOUGHTON 2041 South Africa, ZA |
Contact | C. Nates |
Correspondent | C. Nates SAVE-T-BREATH DISTRIBUTORS C.C. P.O.BOX 87523 HOUGHTON 2041 South Africa, ZA |
Product Code | JOL |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-03 |
Decision Date | 1994-07-19 |