Peri-Patch Glue Mold
FDA 510(k) K810530 · Quinton, Inc.
510(k) numberK810530
Submission
- Device name
- Peri-Patch Glue Mold
- Applicant
- Quinton, Inc.
Mchenry, IL, US - Received
- February 26, 1981
- Decision date
- March 24, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KGZ – Accessories, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K003576 | Q-Tel RMS (Rehabilitation Management System), Model 000503DSI · Abbreviated | 01/25/2001SE |
| K001492 | Quinton Q-Stress, Model 000483DPS · Abbreviated | 08/09/2000SE |
| K992908 | Q-Tel Telemetry System V. 6.0 (ST)DSI · Traditional | 03/06/2000SE |
| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | 04/29/1999SE |
| K971397 | Viewcath 3-D Catheter PullbackITX · Traditional | 08/25/1997SE |
| K964784 | Synergy Cardiology Information System (00431)DPS · Traditional | 08/13/1997SE |
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Questions and answers
When was Peri-Patch Glue Mold cleared by the FDA?
Peri-Patch Glue Mold (K810530) received a 510(k) decision of Substantially Equivalent on March 24, 1981, 26 days after the submission was received.
What is the product code of K810530?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.