The following data is part of a premarket notification filed by Adept-med Intl., Inc. with the FDA for Mcnealy-glassman Viscera Retainer #3202/3204/3206.
Device ID | K870809 |
510k Number | K870809 |
Device Name: | MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 |
Classification | Retainer, Surgical |
Applicant | ADEPT-MED INTL., INC. 3293 SARATOGA LN. PO BOX 1777 Cameron Park, CA 95682 |
Contact | Kathleen Quigley |
Correspondent | Kathleen Quigley ADEPT-MED INTL., INC. 3293 SARATOGA LN. PO BOX 1777 Cameron Park, CA 95682 |
Product Code | GCZ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-03 |
Decision Date | 1987-03-19 |