The following data is part of a premarket notification filed by Aesculap Instruments Corp. with the FDA for Cerullo Suction Regulator.
Device ID | K880704 |
510k Number | K880704 |
Device Name: | CERULLO SUCTION REGULATOR |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | AESCULAP INSTRUMENTS CORP. 875 STANTON RD. Burlingame, CA 94010 |
Contact | Margrit Dubach |
Correspondent | Margrit Dubach AESCULAP INSTRUMENTS CORP. 875 STANTON RD. Burlingame, CA 94010 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-22 |
Decision Date | 1988-03-29 |