The following data is part of a premarket notification filed by Custom Pack Reliability with the FDA for Cpr General Surgery Tray.
Device ID | K960241 |
510k Number | K960241 |
Device Name: | CPR GENERAL SURGERY TRAY |
Classification | General Surgery Tray |
Applicant | CUSTOM PACK RELIABILITY 4207 VINELAND ROAD, M-1 Orlando, FL 32811 |
Contact | Richard L Ellwood |
Correspondent | Richard L Ellwood CUSTOM PACK RELIABILITY 4207 VINELAND ROAD, M-1 Orlando, FL 32811 |
Product Code | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-16 |
Decision Date | 1996-03-22 |