The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Jackson-pratt Hemaduct Wound Drain, Jackson-pratt Gold Hemaduct Wound Drain.
| Device ID | K973703 |
| 510k Number | K973703 |
| Device Name: | JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN |
| Classification | Catheter, Irrigation |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Contact | Joseph A Mertis |
| Correspondent | Joseph A Mertis ALLEGIANCE HEALTHCARE CORP. 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-26 |
| Decision Date | 1997-12-04 |
| Summary: | summary |