The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Ideas Peanut Wand.
Device ID | K926335 |
510k Number | K926335 |
Device Name: | IDEAS PEANUT WAND |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Contact | Lorna K Linville |
Correspondent | Lorna K Linville IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-16 |
Decision Date | 1993-06-24 |