The (Crom) Tester
FDA 510(k) K870767 · Twin City Surgical, Inc.
510(k) numberK870767
Submission
- Device name
- The (Crom) Tester
- Applicant
- Twin City Surgical, Inc.
St. Paul, MN, US - Received
- February 26, 1987
- Decision date
- March 17, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQW – Goniometer, Nonpowered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.1520
- Specialty
- Orthopedic
Other 510(k)s with product code KQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K926237 | O'Brien GoniometerKQW · Traditional | Sgarlato Laboratories, Inc. | 08/02/1993SE |
| K901744 | Dobbhoff(R) Retrieval ForcepsKQW · Traditional | Biosearch Medical Products, Inc. | 07/03/1990SE |
| K850082 | Hand Held GoniometerKQW · Traditional | Chattanooga Group, Inc. | 04/04/1985SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | Fred Sammons, Inc. | 06/24/1983SE |
| K812778 | The Telos EquipmentKQW · Traditional | The Telos Co. | 12/08/1981SE |
| K810441 | Universal GonimeterKQW · Traditional | Fred Sammons, Inc. | 02/27/1981SE |
| K801718 | BK-7513 Stainless Steel GoniometerKQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
| K801717 | BK-7511 Brass GoniometerKQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
| K801716 | BK-7505 Radiopaque Goniometer, 8KQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
| K801715 | BK-7497 Bulb DynamometerKQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
More from Fred Sammons, Inc.
Questions and answers
When was The (Crom) Tester cleared by the FDA?
The (Crom) Tester (K870767) received a 510(k) decision of Substantially Equivalent on March 17, 1987, 19 days after the submission was received.
What is the product code of K870767?
The FDA product code is KQW – Goniometer, Nonpowered, a Class I (low risk) device regulated under 21 CFR 888.1520.