The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for 1500 Series Regulator.
Device ID | K932006 |
510k Number | K932006 |
Device Name: | 1500 SERIES REGULATOR |
Classification | Regulator, Pressure, Gas Cylinder |
Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Contact | John R Selady |
Correspondent | John R Selady PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Product Code | CAN |
CFR Regulation Number | 868.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-21 |
Decision Date | 1993-10-25 |