The following data is part of a premarket notification filed by Powell,goldstein,frazer & Murphy with the FDA for A-v Impulse System Model 6060.
| Device ID | K964425 |
| 510k Number | K964425 |
| Device Name: | A-V IMPULSE SYSTEM MODEL 6060 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | POWELL,GOLDSTEIN,FRAZER & MURPHY 1001 PENNSYLVANIA AVE, N.W. SIXTH FLOOR Wasington, DC 20004 |
| Contact | William H.e. Von Oehsen |
| Correspondent | William H.e. Von Oehsen POWELL,GOLDSTEIN,FRAZER & MURPHY 1001 PENNSYLVANIA AVE, N.W. SIXTH FLOOR Wasington, DC 20004 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-05 |
| Decision Date | 1997-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521101453 | K964425 | 000 |
| 10884521077300 | K964425 | 000 |