The following data is part of a premarket notification filed by Kinetic Medical Products with the FDA for Cephalotomy Scissors.
Device ID | K890388 |
510k Number | K890388 |
Device Name: | CEPHALOTOMY SCISSORS |
Classification | Instrument, Destructive, Fetal, Obstetric |
Applicant | KINETIC MEDICAL PRODUCTS 4934 PEACH ST. Erie, PA 16509 |
Contact | James I Laughner |
Correspondent | James I Laughner KINETIC MEDICAL PRODUCTS 4934 PEACH ST. Erie, PA 16509 |
Product Code | KNB |
CFR Regulation Number | 884.4500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-23 |
Decision Date | 1989-02-13 |