The following data is part of a premarket notification filed by Swift Delivery Products with the FDA for Swift Delivery Product #300.
Device ID | K973942 |
510k Number | K973942 |
Device Name: | SWIFT DELIVERY PRODUCT #300 |
Classification | Extractor, Vacuum, Fetal |
Applicant | SWIFT DELIVERY PRODUCTS 6824 ELK CANYON RD. Oklahoma City, OK 73162 |
Contact | Richard G Lindsay |
Correspondent | Richard G Lindsay SWIFT DELIVERY PRODUCTS 6824 ELK CANYON RD. Oklahoma City, OK 73162 |
Product Code | HDB |
CFR Regulation Number | 884.4340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-26 |
Decision Date | 1997-12-12 |
Summary: | summary |