Cement-Pick
FDA 510(k) K822108 · Bio-Blitz, Inc.
510(k) numberK822108
Submission
- Device name
- Cement-Pick
- Applicant
- Bio-Blitz, Inc.
Mchenry, IL, US - Received
- July 19, 1982
- Decision date
- August 11, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAF – Spatula, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GAF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023688 | Lemaitre Vascular Disposable Vein StripperGAF · Traditional | LeMaitre Vascular, Inc. | 01/30/2003SE |
| K935357 | Snap Reciprocating SawGAF · Traditional | Surgiquip, Inc. | 01/28/1994SE |
| K890374 | Abdominal SpatulaGAF · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K882793 | PMT Fukushima Microsurgical Instrument LineGAF · Traditional | Pmt Corp. | 07/18/1988SE |
More from Pmt Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K822109 | Shovel RetractorNBH · Traditional | 07/30/1982SE |
Questions and answers
When was Cement-Pick cleared by the FDA?
Cement-Pick (K822108) received a 510(k) decision of Substantially Equivalent on August 11, 1982, 23 days after the submission was received.
What is the product code of K822108?
The FDA product code is GAF – Spatula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.