The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Peanut Wand, Modification.
| Device ID | K944067 |
| 510k Number | K944067 |
| Device Name: | PEANUT WAND, MODIFICATION |
| Classification | Endoscope, Battery-powered And Accessories |
| Applicant | IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Contact | Elizabeth M Paul |
| Correspondent | Elizabeth M Paul IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Product Code | GCS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-26 |
| Decision Date | 1994-12-08 |