The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for H-h Rickham Type Reservoir.
Device ID | K853364 |
510k Number | K853364 |
Device Name: | H-H RICKHAM TYPE RESERVOIR |
Classification | Shunt, Central Nervous System And Components |
Applicant | HOLTER-HAUSNER INTL. THIRD AND MILL STREETS P.O. BOX 100 Bridgeport, PA 19405 |
Contact | John R Bolles |
Correspondent | John R Bolles HOLTER-HAUSNER INTL. THIRD AND MILL STREETS P.O. BOX 100 Bridgeport, PA 19405 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-12 |
Decision Date | 1985-09-05 |