The following data is part of a premarket notification filed by Kinetic Medical Products with the FDA for Midwifery/obstetrical Forceps.
Device ID | K890385 |
510k Number | K890385 |
Device Name: | MIDWIFERY/OBSTETRICAL FORCEPS |
Classification | Forceps, Obstetrical |
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 | HDA |
CFR Regulation Number | 884.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-23 |
Decision Date | 1989-03-01 |