The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac Sahara Adult/pediatric Chest Drainage System Model S-1100, S-1200, 2-2100, And S-2200 With Model S-100 Autotr.
| Device ID | K962856 |
| 510k Number | K962856 |
| Device Name: | PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR |
| Classification | Bottle, Collection, Vacuum |
| Applicant | DEKNATEL, INC. 600 AIRPORT ROAD, P.O. BOX 2980 Fall River, MA 02722 -2980 |
| Contact | Dean E Ciporkin |
| Correspondent | Dean E Ciporkin DEKNATEL, INC. 600 AIRPORT ROAD, P.O. BOX 2980 Fall River, MA 02722 -2980 |
| Product Code | KDQ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-22 |
| Decision Date | 1996-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704607363 | K962856 | 000 |
| 44026704428906 | K962856 | 000 |
| 14026704631725 | K962856 | 000 |
| 14026704631664 | K962856 | 000 |
| 34026704921899 | K962856 | 000 |