The following data is part of a premarket notification filed by Laboratoire Ccd C/o Washington Regulatory Services with the FDA for Pipelle De Cornier Endometrial Suction Curette.
Device ID | K881456 |
510k Number | K881456 |
Device Name: | PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE |
Classification | Curette, Suction, Endometrial (and Accessories) |
Applicant | LABORATOIRE CCD C/O WASHINGTON REGULATORY SERVICES 23 WELISEWITZ RD. Ringoes, NJ 08551 |
Contact | Randolph L Cooke |
Correspondent | Randolph L Cooke LABORATOIRE CCD C/O WASHINGTON REGULATORY SERVICES 23 WELISEWITZ RD. Ringoes, NJ 08551 |
Product Code | HHK |
CFR Regulation Number | 884.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-06 |
Decision Date | 1988-10-14 |