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 |