The following data is part of a premarket notification filed by Precision Medical Products, Inc. with the FDA for Bifurcated Vaccinating Needle.
| Device ID | K012515 |
| 510k Number | K012515 |
| Device Name: | BIFURCATED VACCINATING NEEDLE |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | PRECISION MEDICAL PRODUCTS, INC. 12 INDUSTRIAL WAY Denver, PA 17517 |
| Contact | Ronald D Wolfe |
| Correspondent | Ronald D Wolfe PRECISION MEDICAL PRODUCTS, INC. 12 INDUSTRIAL WAY Denver, PA 17517 |
| Product Code | LDH |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10868652000222 | K012515 | 000 |