The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Pre-gaged Balanced Cuff W/sylgard Antimicro. Treat.
| Device ID | K884421 |
| 510k Number | K884421 |
| Device Name: | PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT |
| Classification | Blood Pressure Cuff |
| Applicant | PYMAH CORP. 89 ROUTE 206 PO BOX 1114 Somerville, NJ 08876 |
| Contact | Thomas Thackston |
| Correspondent | Thomas Thackston 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 | 1988-10-20 |
| Decision Date | 1989-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094225433 | K884421 | 000 |
| 50885632115378 | K884421 | 000 |
| 50885632115361 | K884421 | 000 |
| 50885632115354 | K884421 | 000 |
| 50885632115347 | K884421 | 000 |
| 50885632115330 | K884421 | 000 |
| 50885632115323 | K884421 | 000 |
| 50885632115316 | K884421 | 000 |
| 50885632115309 | K884421 | 000 |
| 50885632115293 | K884421 | 000 |
| 50885632115286 | K884421 | 000 |
| 50885632115279 | K884421 | 000 |
| 50885632115385 | K884421 | 000 |
| 50885632115392 | K884421 | 000 |
| 50885632115408 | K884421 | 000 |
| 50885632115538 | K884421 | 000 |
| 50885632115514 | K884421 | 000 |
| 50885632115491 | K884421 | 000 |
| 50885632115484 | K884421 | 000 |
| 50885632115477 | K884421 | 000 |
| 50885632115460 | K884421 | 000 |
| 50885632115453 | K884421 | 000 |
| 50885632115446 | K884421 | 000 |
| 50885632115439 | K884421 | 000 |
| 50885632115422 | K884421 | 000 |
| 50885632115415 | K884421 | 000 |
| 50885632115262 | K884421 | 000 |