Shovel Retractor
FDA 510(k) K822109 · Bio-Blitz, Inc.
510(k) numberK822109
Submission
- Device name
- Shovel Retractor
- Applicant
- Bio-Blitz, Inc.
Mchenry, IL, US - Received
- July 19, 1982
- Decision date
- July 30, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NBH – Accessories, Arthroscopic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.1100
- Specialty
- Orthopedic
Other 510(k)s with product code NBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K822560 | Irrigation SetNBH · Traditional | Utah Medical Products, Inc. | 12/03/1982SE |
More from Utah Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822108 | Cement-PickGAF · Traditional | 08/11/1982SE |
Questions and answers
When was Shovel Retractor cleared by the FDA?
Shovel Retractor (K822109) received a 510(k) decision of Substantially Equivalent on July 30, 1982, 11 days after the submission was received.
What is the product code of K822109?
The FDA product code is NBH – Accessories, Arthroscopic, a Class I (low risk) device regulated under 21 CFR 888.1100.