The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Clear Hub Spinal Needle 14ga, 16ga, 17ga, 18ga, 20ga, 21ga, 22ga, 25ga, 26ga And 27ga.
| Device ID | K982269 |
| 510k Number | K982269 |
| Device Name: | CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA |
| Classification | Needle, Spinal, Short Term |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Contact | Zarina B Ilgrami |
| Correspondent | Zarina B Ilgrami ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Product Code | MIA |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-29 |
| Decision Date | 1998-07-23 |
| Summary: | summary |