The following data is part of a premarket notification filed by Apple Medical Corp. with the FDA for Lweet Cone Biopsy Instrument.
| Device ID | K961460 |
| 510k Number | K961460 |
| Device Name: | LWEET CONE BIOPSY INSTRUMENT |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | APPLE MEDICAL CORP. 23 WEILSEWITZ RD. Ringoes, NJ 08551 |
| Contact | Randolph L Cooke |
| Correspondent | Randolph L Cooke APPLE MEDICAL CORP. 23 WEILSEWITZ RD. Ringoes, NJ 08551 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-16 |
| Decision Date | 1996-11-19 |