The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for H-h Hunter Passive Tendon Implant.
| Device ID | K853436 |
| 510k Number | K853436 |
| Device Name: | H-H HUNTER PASSIVE TENDON IMPLANT |
| Classification | Spatula, Orthopedic |
| 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 | HXR |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-15 |
| Decision Date | 1985-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420132369 | K853436 | 000 |
| 00840420132352 | K853436 | 000 |
| 00840420132345 | K853436 | 000 |
| 00840420132338 | K853436 | 000 |
| 00840420128973 | K853436 | 000 |
| 00840420128966 | K853436 | 000 |
| 00840420128959 | K853436 | 000 |
| 00840420128942 | K853436 | 000 |
| 00840420128935 | K853436 | 000 |