The following data is part of a premarket notification filed by Brenner Metal Prod Corp. with the FDA for Rod, Irrigator, Supporting Telescoping, Type.
Device ID | K863688 |
510k Number | K863688 |
Device Name: | ROD, IRRIGATOR, SUPPORTING TELESCOPING, TYPE |
Classification | Bed, Manual |
Applicant | BRENNER METAL PROD CORP. 16 MAIN AVE. Wallington, NJ 07057 |
Contact | Brenner, V.p. |
Correspondent | Brenner, V.p. BRENNER METAL PROD CORP. 16 MAIN AVE. Wallington, NJ 07057 |
Product Code | FNJ |
CFR Regulation Number | 880.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-19 |
Decision Date | 1987-01-20 |