The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for H-h Catheter Passers(tacl Design.
| Device ID | K853370 |
| 510k Number | K853370 |
| Device Name: | H-H CATHETER PASSERS(TACL DESIGN |
| Classification | Instrument, Shunt System Implantation |
| 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 | GYK |
| CFR Regulation Number | 882.4545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760124134810 | K853370 | 000 |
| 03760124134803 | K853370 | 000 |
| 03760124133813 | K853370 | 000 |