The following data is part of a premarket notification filed by Shampaine/wilson with the FDA for Cat. No. S-5300-e Birthing Bed.
Device ID | K852171 |
510k Number | K852171 |
Device Name: | CAT. NO. S-5300-E BIRTHING BED |
Classification | Table, Obstetric (and Accessories) |
Applicant | SHAMPAINE/WILSON 1920 S. JEFFERSON AVE. St. Louis, MO 63104 |
Contact | Kevin Randich |
Correspondent | Kevin Randich SHAMPAINE/WILSON 1920 S. JEFFERSON AVE. St. Louis, MO 63104 |
Product Code | KNC |
CFR Regulation Number | 884.4900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-20 |
Decision Date | 1985-08-30 |