The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Redyrob-closed Wound Drainage System.
| Device ID | K972703 |
| 510k Number | K972703 |
| Device Name: | REDYROB-CLOSED WOUND DRAINAGE SYSTEM |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | B. BRAUN MEDICAL, INC. 824 12TH AVE. Bethlehem, PA 18018 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge B. BRAUN MEDICAL, INC. 824 12TH AVE. Bethlehem, PA 18018 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-18 |
| Decision Date | 1997-10-01 |
| Summary: | summary |