The following data is part of a premarket notification filed by Eastmed Enterprises Inc. with the FDA for 15 Millimeter Male And Female Adapters.
Device ID | K884072 |
510k Number | K884072 |
Device Name: | 15 MILLIMETER MALE AND FEMALE ADAPTERS |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | EASTMED ENTERPRISES INC. 5 PEMBURY COURT Marlton, NJ 08053 |
Contact | Supti Putatunda |
Correspondent | Supti Putatunda EASTMED ENTERPRISES INC. 5 PEMBURY COURT Marlton, NJ 08053 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-27 |
Decision Date | 1988-10-07 |