The following data is part of a premarket notification filed by Global Medical Products, Inc. with the FDA for H.v. Pulse Lavage (l31 Series).
| Device ID | K970916 |
| 510k Number | K970916 |
| Device Name: | H.V. PULSE LAVAGE (L31 SERIES) |
| Classification | Lavage, Jet |
| Applicant | GLOBAL MEDICAL PRODUCTS, INC. 1725 SOUTH RAINBOW BLVD., #25 Las Vegas, NV 89146 |
| Contact | Tonya Balaban |
| Correspondent | Tonya Balaban GLOBAL MEDICAL PRODUCTS, INC. 1725 SOUTH RAINBOW BLVD., #25 Las Vegas, NV 89146 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-12 |
| Decision Date | 1997-06-20 |
| Summary: | summary |