The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Pm3300 Intermittent Vacuum.
| Device ID | K944479 |
| 510k Number | K944479 |
| Device Name: | PM3300 INTERMITTENT VACUUM |
| Classification | Regulator, Vacuum |
| Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Contact | Michael A Krupa |
| Correspondent | Michael A Krupa PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Product Code | KDP |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-13 |
| Decision Date | 1994-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855887006474 | K944479 | 000 |
| 00850027043319 | K944479 | 000 |
| 00850027043258 | K944479 | 000 |
| 00850027043241 | K944479 | 000 |
| 00850027043234 | K944479 | 000 |
| 00850027043432 | K944479 | 000 |
| 00850027043425 | K944479 | 000 |
| 00850027043418 | K944479 | 000 |
| 00850027043401 | K944479 | 000 |
| 00850027043364 | K944479 | 000 |
| 00850027043357 | K944479 | 000 |
| 00850027043340 | K944479 | 000 |
| 00850027043326 | K944479 | 000 |
| 00850027043456 | K944479 | 000 |
| 00855887006092 | K944479 | 000 |
| 00855887006443 | K944479 | 000 |
| 00855887006412 | K944479 | 000 |
| 00855887006405 | K944479 | 000 |
| 00855887006375 | K944479 | 000 |
| 00855887006344 | K944479 | 000 |
| 00855887006313 | K944479 | 000 |
| 00855887006207 | K944479 | 000 |
| 00855887006191 | K944479 | 000 |
| 00855887006184 | K944479 | 000 |
| 00855887006177 | K944479 | 000 |
| 00855887006108 | K944479 | 000 |
| 00850027043333 | K944479 | 000 |