The following data is part of a premarket notification filed by Beech Medical Products, Inc. with the FDA for Beech Pro Lok Fixed.
Device ID | K946082 |
510k Number | K946082 |
Device Name: | BEECH PRO LOK FIXED |
Classification | Set, Administration, Intravascular |
Applicant | BEECH MEDICAL PRODUCTS, INC. 241 LACKLAND DR. Middlesex, NJ 08846 |
Contact | John Romano |
Correspondent | John Romano BEECH MEDICAL PRODUCTS, INC. 241 LACKLAND DR. Middlesex, NJ 08846 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-13 |
Decision Date | 1995-03-13 |