The following data is part of a premarket notification filed by Adel Medical Ltd. with the FDA for Labor-delivery Stretch/bed.
Device ID | K861030 |
510k Number | K861030 |
Device Name: | LABOR-DELIVERY STRETCH/BED |
Classification | Table, Obstetric (and Accessories) |
Applicant | ADEL MEDICAL LTD. 16700 S.E. 120TH AVE. P.O. BOX 542 Clackamas, OR 97015 |
Contact | Dave Cole |
Correspondent | Dave Cole ADEL MEDICAL LTD. 16700 S.E. 120TH AVE. P.O. BOX 542 Clackamas, OR 97015 |
Product Code | KNC |
CFR Regulation Number | 884.4900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-18 |
Decision Date | 1986-04-23 |