The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Balanced(tm) Nylon Bladder.
Device ID | K930604 |
510k Number | K930604 |
Device Name: | BALANCED(TM) NYLON BLADDER |
Classification | Blood Pressure Cuff |
Applicant | PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
Contact | Robert A Lang |
Correspondent | Robert A Lang PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-05 |
Decision Date | 1993-04-30 |