The following data is part of a premarket notification filed by Marquette Medical, Inc. with the FDA for Subcutaneous Infusion Set.
| Device ID | K920537 |
| 510k Number | K920537 |
| Device Name: | SUBCUTANEOUS INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MARQUETTE MEDICAL, INC. 2134 ESPEY CT. #7 Crofton, MD 21114 |
| Contact | Marquette Jr. |
| Correspondent | Marquette Jr. MARQUETTE MEDICAL, INC. 2134 ESPEY CT. #7 Crofton, MD 21114 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-05 |
| Decision Date | 1992-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852323007323 | K920537 | 000 |
| 00852323007149 | K920537 | 000 |
| 00852323007132 | K920537 | 000 |
| 00852323007125 | K920537 | 000 |
| 00852323007118 | K920537 | 000 |
| 00852323007101 | K920537 | 000 |
| 00852323007095 | K920537 | 000 |
| 00852323007088 | K920537 | 000 |
| 00852323007071 | K920537 | 000 |
| 00852323007064 | K920537 | 000 |
| 00852323007057 | K920537 | 000 |
| 00852323007040 | K920537 | 000 |
| 00852323007033 | K920537 | 000 |
| 00852323007026 | K920537 | 000 |
| 00852323007019 | K920537 | 000 |
| 00852323007156 | K920537 | 000 |
| 00852323007163 | K920537 | 000 |
| 00852323007170 | K920537 | 000 |
| 00852323007316 | K920537 | 000 |
| 00852323007309 | K920537 | 000 |
| 00852323007293 | K920537 | 000 |
| 00852323007286 | K920537 | 000 |
| 00852323007279 | K920537 | 000 |
| 00852323007262 | K920537 | 000 |
| 00852323007255 | K920537 | 000 |
| 00852323007248 | K920537 | 000 |
| 00852323007231 | K920537 | 000 |
| 00852323007224 | K920537 | 000 |
| 00852323007217 | K920537 | 000 |
| 00852323007200 | K920537 | 000 |
| 00852323007194 | K920537 | 000 |
| 00852323007187 | K920537 | 000 |
| 00852323007002 | K920537 | 000 |