The following data is part of a premarket notification filed by Pulley-kellam Co., Inc. with the FDA for Lorraine Dsl Labor & Delivery Bed.
Device ID | K842962 |
510k Number | K842962 |
Device Name: | LORRAINE DSL LABOR & DELIVERY BED |
Classification | Table, Obstetric (and Accessories) |
Applicant | PULLEY-KELLAM CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNC |
CFR Regulation Number | 884.4900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-27 |
Decision Date | 1984-09-25 |