The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll Autoclavable Internal Handles.
| Device ID | K963781 |
| 510k Number | K963781 |
| Device Name: | ZOLL AUTOCLAVABLE INTERNAL HANDLES |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
| Contact | Maura Mcguire |
| Correspondent | Maura Mcguire ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-20 |
| Decision Date | 1997-05-20 |