The following data is part of a premarket notification filed by Sharpoint, Inc. with the FDA for Surgical Knife.
| Device ID | K861947 |
| 510k Number | K861947 |
| Device Name: | SURGICAL KNIFE |
| Classification | Knife, Surgical |
| Applicant | SHARPOINT, INC. 2850 WINDMILL RD. Reading, PA 19608 |
| Contact | David A Yates |
| Correspondent | David A Yates SHARPOINT, INC. 2850 WINDMILL RD. Reading, PA 19608 |
| Product Code | EMF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782026934 | K861947 | 000 |
| 10848782025975 | K861947 | 000 |
| 20848782025958 | K861947 | 000 |
| 10848782025944 | K861947 | 000 |
| 10848782025883 | K861947 | 000 |
| 10848782025838 | K861947 | 000 |
| 10848782025784 | K861947 | 000 |
| 10848782025760 | K861947 | 000 |
| 10848782025685 | K861947 | 000 |
| 10848782025678 | K861947 | 000 |
| 10848782025654 | K861947 | 000 |
| 10848782025630 | K861947 | 000 |
| 10848782025609 | K861947 | 000 |
| 10848782025579 | K861947 | 000 |
| 10848782025548 | K861947 | 000 |
| 10848782025982 | K861947 | 000 |
| 10848782025999 | K861947 | 000 |
| 10848782026897 | K861947 | 000 |
| 10848782026583 | K861947 | 000 |
| 10848782026576 | K861947 | 000 |
| 10848782026569 | K861947 | 000 |
| 10848782026538 | K861947 | 000 |
| 10848782026439 | K861947 | 000 |
| 10848782026385 | K861947 | 000 |
| 10848782026248 | K861947 | 000 |
| 10848782026170 | K861947 | 000 |
| 10848782026132 | K861947 | 000 |
| 10848782026125 | K861947 | 000 |
| 10848782026101 | K861947 | 000 |
| 10848782026057 | K861947 | 000 |
| 10848782026019 | K861947 | 000 |
| 10848782025524 | K861947 | 000 |