The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Obstetrical Safety System.
Device ID | K884868 |
510k Number | K884868 |
Device Name: | OBSTETRICAL SAFETY SYSTEM |
Classification | Table, Obstetric (and Accessories) |
Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | David W Schlerf |
Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | KNC |
CFR Regulation Number | 884.4900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-21 |
Decision Date | 1989-03-01 |