The following data is part of a premarket notification filed by D.l. Nelson And Assoc., Inc. with the FDA for Endocyte Tm.
| Device ID | K944238 |
| 510k Number | K944238 |
| Device Name: | ENDOCYTE TM |
| Classification | Curette, Uterine |
| Applicant | D.L. NELSON AND ASSOC., INC. 2902 MARLIN CIR. Atlanta, GA 30341 -5118 |
| Contact | Dennis L Nelson |
| Correspondent | Dennis L Nelson D.L. NELSON AND ASSOC., INC. 2902 MARLIN CIR. Atlanta, GA 30341 -5118 |
| Product Code | HCY |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-31 |
| Decision Date | 1995-09-15 |