The following data is part of a premarket notification filed by Apple Medical Corp. with the FDA for Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 And 158.
| Device ID | K061651 |
| 510k Number | K061651 |
| Device Name: | FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | APPLE MEDICAL CORP. 28 LORD RD., UNIT 135 Marlboro, MA 01752 |
| Contact | John C Pulford |
| Correspondent | John C Pulford APPLE MEDICAL CORP. 28 LORD RD., UNIT 135 Marlboro, MA 01752 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-13 |
| Decision Date | 2006-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937003750 | K061651 | 000 |
| 20888937003776 | K061651 | 000 |
| 20888937003769 | K061651 | 000 |
| 20888937003745 | K061651 | 000 |
| 20888937003738 | K061651 | 000 |
| 20888937003721 | K061651 | 000 |
| 20888937003714 | K061651 | 000 |
| 20888937003707 | K061651 | 000 |