The following data is part of a premarket notification filed by American Medical Electronics, Inc. with the FDA for Ame Pinsite Shield(tm).
| Device ID | K884798 |
| 510k Number | K884798 |
| Device Name: | AME PINSITE SHIELD(TM) |
| Classification | Component, Traction, Invasive |
| Applicant | AMERICAN MEDICAL ELECTRONICS, INC. 4125 KELLER SPRINGS RD., STE 144 Dallas, TX 75244 |
| Contact | Clayton Thacker |
| Correspondent | Clayton Thacker AMERICAN MEDICAL ELECTRONICS, INC. 4125 KELLER SPRINGS RD., STE 144 Dallas, TX 75244 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-16 |
| Decision Date | 1989-02-10 |