The following data is part of a premarket notification filed by Healthcare Technologies Resources, Inc. with the FDA for S.s.t. Surgical Thimble.
| Device ID | K895603 |
| 510k Number | K895603 |
| Device Name: | S.S.T. SURGICAL THIMBLE |
| Classification | Surgeon's Gloves |
| Applicant | HEALTHCARE TECHNOLOGIES RESOURCES, INC. 3160 NORTH TRUCKEE LANE, SUITE 21 Sparks, NV 89431 |
| Contact | Michael E Fisher |
| Correspondent | Michael E Fisher HEALTHCARE TECHNOLOGIES RESOURCES, INC. 3160 NORTH TRUCKEE LANE, SUITE 21 Sparks, NV 89431 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-18 |
| Decision Date | 1989-10-06 |