The following data is part of a premarket notification filed by Adept-med Intl., Inc. with the FDA for Goott Balfour Blade.
| Device ID | K893871 |
| 510k Number | K893871 |
| Device Name: | GOOTT BALFOUR BLADE |
| Classification | Retractor |
| Applicant | ADEPT-MED INTL., INC. 3293 SARATOGA LN. PO BOX 1777 Cameron Park, CA 95682 |
| Contact | Kathleen Quigley |
| Correspondent | Kathleen Quigley ADEPT-MED INTL., INC. 3293 SARATOGA LN. PO BOX 1777 Cameron Park, CA 95682 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-26 |
| Decision Date | 1989-08-03 |