The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Macropore Medical/surgical Paper Tape.
| Device ID | K884108 |
| 510k Number | K884108 |
| Device Name: | MACROPORE MEDICAL/SURGICAL PAPER TAPE |
| Classification | Tape And Bandage, Adhesive |
| Applicant | LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
| Contact | Dorothy Woessner |
| Correspondent | Dorothy Woessner LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-29 |
| Decision Date | 1988-11-10 |