The following data is part of a premarket notification filed by Consolidated Medical Equipment, Inc. with the FDA for Plura-gard Chest Drainage System.
| Device ID | K844942 |
| 510k Number | K844942 |
| Device Name: | PLURA-GARD CHEST DRAINAGE SYSTEM |
| Classification | Bottle, Collection, Vacuum |
| Applicant | CONSOLIDATED MEDICAL EQUIPMENT, INC. 310 BROAD ST. Utica, NY 13501 |
| Contact | William W Abraham |
| Correspondent | William W Abraham CONSOLIDATED MEDICAL EQUIPMENT, INC. 310 BROAD ST. Utica, NY 13501 |
| Product Code | KDQ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-20 |
| Decision Date | 1985-03-12 |