The following data is part of a premarket notification filed by Custom Pack Reliability with the FDA for Cpr D & C Tray.
Device ID | K960239 |
510k Number | K960239 |
Device Name: | CPR D & C TRAY |
Classification | Curette, Suction, Endometrial (and Accessories) |
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 | HHK |
CFR Regulation Number | 884.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-16 |
Decision Date | 1996-05-23 |