The following data is part of a premarket notification filed by Trimline Medical Products Corp. with the FDA for Tempa-kuff Soft Blood Pressure Cuff, Model 39xxx ; Vinyl,model 99xxx.
| Device ID | K080189 |
| 510k Number | K080189 |
| Device Name: | TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX |
| Classification | Blood Pressure Cuff |
| Applicant | TRIMLINE MEDICAL PRODUCTS CORP. 34 COLUMBIA AVE. Branchburg, NJ 08876 |
| Contact | Nancy Skocypec |
| Correspondent | Nancy Skocypec TRIMLINE MEDICAL PRODUCTS CORP. 34 COLUMBIA AVE. Branchburg, NJ 08876 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-25 |
| Decision Date | 2008-08-15 |