The following data is part of a premarket notification filed by Delta Medical Manuf, Inc. with the FDA for 3p (pulmonary Percussive Pack).
| Device ID | K931988 |
| 510k Number | K931988 |
| Device Name: | 3P (PULMONARY PERCUSSIVE PACK) |
| Classification | Percussor, Powered-electric |
| Applicant | DELTA MEDICAL MANUF, INC. P.O. BOX 52038 Raleigh, NC 27612 |
| Contact | Den Ravely |
| Correspondent | Den Ravely DELTA MEDICAL MANUF, INC. P.O. BOX 52038 Raleigh, NC 27612 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-22 |
| Decision Date | 1994-10-28 |