The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Pymah Pre-gaged Balanced Tempa-kuff.
| Device ID | K903379 |
| 510k Number | K903379 |
| Device Name: | PYMAH PRE-GAGED BALANCED TEMPA-KUFF |
| Classification | Blood Pressure Cuff |
| Applicant | PYMAH CORP. 8904 PADDOCK LN. Potomac, MD 20854 |
| Contact | L Konopko |
| Correspondent | L Konopko PYMAH CORP. 8904 PADDOCK LN. Potomac, MD 20854 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-30 |
| Decision Date | 1990-10-19 |